logo
Contact Us

Author: admin

Categories
Blog

THE UPS AND DOWNS OF CIPM PRICE REVISIONS

THE UPS AND DOWNS OF CIPM PRICE REVISIONS

The Spanish healthcare system is notorious for being cost-conscious. With COVID-19 acting as a major setback in terms of budget allocation and public debt (1), this could have consequential knock-on effects on Spain’s willingness to pay for drugs. One mechanism that allows them to exercise their predisposition to implement budget control is drug pricing.

How are drugs in Spain priced?

The Comisión Interministerial de Precios de Medicamentos y Productos Sanitarios (CIPM) is the pricing committee under the Ministry of Health (MoH) responsible for pricing drugs in Spain. Following a drug’s positive assessment for reimbursement by the MoH, the CIPM sets maximum ex-factory prices based on value assessments, then publishes these prices. Moreover, the CIPM employs reference pricing – a system that allows them to annually exert downward pressure on groupings of drugs based on their active ingredient or their INN. Through this, all drug prices in a reference grouping are recalculated downwards. These measures also apply to generics that contain the same active ingredient.

Whilst they have a set criteria for funding medicinal products, their pricing reports are not public leading to accusations for a lack of transparency with the existence of seemingly arbitrary price reviews and price reductions.

Ultimately, these pricing controls have led the CIPM to be viewed as a harsh institution. However, our review of the CIPM pricing revisions demonstrates that pricing increases do happen (2), which led us to explore further.

What happens in the CIPM’s price revisions?​

To investigate these concepts further, we accomplished an analysis of CIPM pricing revisions from 30th May 2019 to 7th April 2021 (2).

The CIPM executed price revisions through stock keeping units (SKUs), which refer to the specific price increase or decrease of every unit. Thus, single drug would have several SKUs if manufactured and reimbursed for a variety of dosages. During this time frame, the CIPM published 71 SKU price increases and 54 SKU decreases. This fact alone is surprising, considering that increases in SKU price were not expected of the CIPM.

Upon closer analysis, we ordered all the drugs according to their ex-factory SKU price to establish whether there was a relationship between baseline price level and the likelihood of a price increase of decrease. All drugs under the lower quartile had experienced a price increase, while the third quartile exhibited the most price decreases.

Number of price increases and decreases per quartile baseline SKU price from May 2019-April 2021

Why are there so many price decreases in the €22.40-33.00 range?

It is imperative to comprehend what led to the bulk of price decreases in the third quartile, and what could have motivated the sudden fall of multiple products.

Number of price increases and decreases per CIPM price revision

The decreases in SKU prices in the third quartile are accredited to the pricing report published in February 2020 (3), with 45 drug decreases for asthma and pulmonary disease.

What was the justification given for the price decreases?

The Minister of Health Salvador Illa in the Health Commission held in February of last year specifically stated drugs for asthma and COPD as an example of how the ”new pharmaceutical policy strategy” and the latest framework agreement has saved approximately €30 million (4). ​

On the report, the specific reason provided for every SKU decreases in price was the same across the board – Article 96.2 (3). Under this article, price is modified by ”changes in economic, technical, health circumstances, or in assessment of its therapeutic utility”. Whilst this reasoning appears vague, we are aware of the larger economic incentive in place.​

What does this mean for future price revisions?

The case of asthma and COPD could be indicative of future price revisions by the CIPM, especially for chronic disease products that have the potential to yield a significant amount of savings and ultimately reduce budget impact.
 
The lack of transparency in CIPM price revisions ensues an intense level of unpredictability for pharmaceutical manufacturers in the Spanish market. Arbitrary reductions in price remain a cause of concern despite the observed modest increases in price. When coupled with the recent introduction of the pharmacoeconomic assessment in the reimbursement process (6) and the much expected COVID-19 budgetary pressures, the future of Spain’s pharmaceutical market remains full of uncertainty.
Sources
  1. https://www.funcas.es/wp-content/uploads/2020/10/Sanz-y-Romero_9-5.pdf​
  2. https://www.mscbs.gob.es/profesionales/farmacia/CIPMyPS.htm​
  3. https://www.mscbs.gob.es/profesionales/farmacia/pdf/ACUERDOS_DE_LA_CIPM_198_web.pdf ​
  4. https://www.diariofarma.com/2020/02/27/eficiencia-y-sostenibilidad-guiaran-la-politica-farmaceutica-de-illa ​
  5. https://www.consalud.es/pacientes/epoc-cuarta-causa-muerte-espana-olvidada-sanidad-desconocida-sociedad_88349_102.html ​
  6. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/2021/IPT_32-2021-Talzenna.pdf?x60265
About the author

Marianna Reyes

Marianna graduated from the University College London with a BSc in Human Sciences, a multidisciplinary biosciences degree. At Access Infinity, Marianna works on Consulting projects such as a CNS opportunity assessment, extensive nephrology landscape researching, and global hepatology value message development and pricing. She also has deep knowledge of Spanish and Swedish price and reimbursement systems.
Categories
Blog

MARKET ACCESS IS EASY, THERE ARE ONLY 5 STEPS

MARKET ACCESS IS EASY, THERE ARE ONLY 5 STEPS

As we welcome our 6th director to Access Infinity and take our collective market access experience to well over a century, we have been thinking about what sets us apart as a market access consultancy. Our digital solutions are an obvious answer with many thousands of expert hours going into their design and development (1), allowing us as consultants to work faster, smarter, and more rigorously than we have ever been able before. These are the distilled essence of our ongoing learning in market access. But one of our true differences is our passion for sharing what we have learned about market access with our colleagues and clients. For those setting out on the journey, there are some great foundational training courses, including the very popular CELforPharma foundation course (2), but if you want to build your career in this space, how would you do it?

0 +
years industry experience
0 K
hours pharma experience
0 +
people helped on their market access learning journey

The 5 steps to market access mastery:

We work with many talented linguists, and like any new language it’s often useful to connect the words or concepts back to something we understand. Whether you have a background in biosciences or business, maths or marketing, there are some basic forms of the market access language which are familiar. At the most basic level, we bring our experience as consumers of healthcare in our home countries that gives us a solid starting point. Start with what you know and build out from there.

There is a wealth of information out there to learn about market access if you just know where to look. Learning where those facts are, how to quickly access them, and turn them into digestible analysis is invaluable. Knowing how to navigate a 300-page HTA document or the G-BA website in minutes is great, but it is just as important to learn what you would not be able to find there. Find someone to show you around and help you work out what’s important and what isn’t

Once you have looked at the market access landscapes of a few different health systems, HTA processes, assessments or even therapy areas, you will soon start to see patterns emerging. These trends will turn into your own unique set of heuristics to guide and give you an intuition on how to answer some of the trickier market access problems. Build on the patterns and similarities which appear to you and are shared by others.

Healthcare is complicated and the commercial business of healthcare even more so. Every health system has their own way of doing things and they are rarely simple. From the nuances of health economic analyses to the commercial attributes of country distribution channels, a true sign of the skill is not only collecting the similarities but then understanding which differences are important. Try to embrace the complexity, it might seen overwhelming but it is worth it.

Malcolm Gladwell (3) famously and controversially cited the 10,000 hours of practice (4) required for mastery of a skill. In market access consulting terms, this adds up to about 6 years of work in the world of payer insights, evidence generation and commercial planning. The often-under-recognised aspect of this 10,000-hour estimate is that the practice must be deliberate. Therefore, it is not enough to just spend the time, we must be dedicated, focussed, and intentional in our learning so we can apply what we know to the vast range of market access needs faced by the industry. Try to structure your continuing learning, sharing what you know with others is a great way to do that.

Related Links
  1. https://access-infinity.com/thought_leadership/tools-articles/nuro/
  2. https://www.celforpharma.com/course/understanding-market-access-payers-europe
  3. https://en.wikipedia.org/wiki/Outliers_(book)
  4. https://psycnet.apa.org/record/1993-40718-001
About the author

Nick Proctor

Nick has spent the last 20 years helping pharmaceutical companies meet their development and commercial objectives and in that time he has been fortunate enough to learn from the finest mentors, advisors and coaches in the industry. During his time in price, reimbursement and market access consultancy he has realised that the key to delivering great client work is a great team and a common understanding of the challenges, so Nick is always looking for new ways to help colleagues and clients keep learning about payers and their world. Nick is a tutor, coach and lecturer in market access and has been a member of the expert faculty at CELforPharma for almost 7 years. Nick has a PhD in medicine and pharmacy from the University of Manchester and worked on his postdoctoral research at the University of Sheffield.
Categories
Blog

BALANCING A FASTER TIME TO LAUNCH VS OPTIMAL ACCESS: CONDITIONAL MARKETING AUTHORISATION AND HTA BODIES

Generating comprehensive data in rare diseases or chronic progressive conditions, can be challenging often requiring lengthy study durations and very high investment. The European Medicines Agency (EMA) therefore considers granting early market authorisation of a product for seriously debilitating, life-threatening, or rare diseases. Given the current global climate from challenges posed by COVID-19, even more interest has been directed towards fast-tracking regulatory approval. Conditional Marketing Authorisation (CMA) is a regulatory pathway for such diseases that enables timely access to therapies.

Our question is: what are the HTA implications of launching with a CMA?

1. Among the many attributes of these products, our initial exploration was to look at the HTA outcomes for drugs with orphan or for oncology indications.

2. We wanted to take a closer look at those 40 drugs. We categorised them by their orphan designation and clinical evidence packages to see if categorisations commonly sought a CMA.

Of 40 products launched with CMA:

  • Among non-orphan drugs, majority of the products were for oncology indications
  • 0% have since converted to CMA to SMA, with the average conversion being 4 years
     
  • The remaining 70% are still approved for use under CMA
  • + 1 Holoclar – a highly specialised stem cell therapy that only had observational clinical studies submitted

3. We did a deep-dive into the HTA outcomes of the 40 drugs that launched via a CMA. The purpose of our analysis was to explore HTA outcomes of CMA products in indicative HTA markets.

Among the many attributes of these products, our initial exploration was to look at the HTA outcomes for drugs with orphan or for oncology indications.

HTA Outcomes achieved by oncology and non-oncology indications that launched with a CMA in FR, DE, and UK

Majority of the products not assessed by respective HTA body are very recent entrants and likely to be assessed in the near future.

In Germany, a clear majority of drugs that were assessed were given ‘not quantifiable’ or ‘added benefit not proven’ as outcomes. The majority of the outcomes are not quantifiable, which may be due to the additional clinical benefit rating in certain circumstances for orphan drugs under AMNOG.

In the UK, more favourable HTA outcomes were observed from the 40 drugs that launched via a CMA in comparison to both France and Germany. Like France and Germany, orphan drugs also achieved more favourable HTA outcomes in the UK as opposed to non-orphan drugs.

Interestingly, the most common HTA outcome in the UK was recommended via CDF, which shows that oncology drugs may be the main driver for CMA products obtaining a favourable HTA outcome. Moreover, the future prospect of an Innovative Medicines Fund for the UK may act in a similar way to the CDF for oncology drugs, opening the opportunity for non-oncology products to pursue a conditional reimbursement route.

HTA Outcomes achieved by Oncology and Non-Oncology indications that launched with a CMA in FR, DE, and UK

Building on our previous analysis of orphan drugs, we decided to take a closer look at non-oncology vs. oncology drugs. The country that exhibited a noticeable difference in non-oncology vs. oncology HTA outcomes is the UK with most drugs recommended via CDF. This proves that oncology drugs launching via a CMA achieve favourable HTA outcomes because of the special considerations of the CDF.

4. We collated the obvious key observations, and we are now prepared to ask the bigger questions.

Our information database allowed us to quickly obtain all the data we needed to complete our analysis exploring links between CMAs on the type of evidence submitted and HTA outcome.

 

We made five key observations.
  • All products with CMA were subject to the same degree of evaluation by HTA bodies as SMA. Thus, pharma companies will not be granted a less rigorous process had they already launched via a CMA.
  • Almost half (44%) of drugs that attained CMA status were drugs that submitted PII clinical trial data. This was expected given that CMAs are used for extraordinary situations that necessitate a drug in the market as soon as possible.
  • In France and Germany, new product evaluation process do not seem to disadvantage CMA drugs.
  • In the UK, most drugs were recommended via CDF, noting that oncology drugs launching via a CMA achieve favourable HTA outcomes. The possibility of an Innovative Drugs Fund may have implications for other non-oncological indications. The relatively large proportion of oncology treatments in this sample may be the reason why the UK seemed to grant more favourable HTA outcomes.
  • If the link between CMA status and HTA outcome is also supported by commercially attractive price decision, this route could be considered as an attractive strategic option alongside access pathways such as the UK’s Early Access to Medicines Scheme (EAMS) or France’s Autorisation Temporaire d’Utilisation (ATU).

Now that we have established our observations, we are now in the position to ask deeper questions. Through our observations, we are able to pinpoint criticalities that will reshape our understanding of the CMA pathway and its implications on HTA and price.

If you are considering launching your drug via a CMA or if you have an orphan drug, reach out and find out more about what we can do for you.

Related Links

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation

About the authors

Dr. Jesvin Samuel

Jesvin is an immunologist by training, and has 9 years of experience in translational research in haemato-oncology. He has successfully published in leading journals such as NEJM, Blood, and the British Journal of Haematology. Jesvin has transferred his expertise to Consulting with Access Infinity, and has managed numerous global market access strategy projects.

Marianna Reyes

Marianna graduated from the University College London with a BSc in Human Sciences, a multidisciplinary biosciences degree. At Access Infinity, Marianna works on both digital solutions and Consulting projects such as a CNS opportunity assessment and global hepatology value message development and pricing. She also has deep knowledge of Spanish and Swedish price and reimbursement systems.
Categories
Blog

HOW GARDASIL RESHAPED THE VACCINES MARKET

Generated through leveraging our vaccine expertise from multiple client projects

COVID-19 has enhanced interest in infectious diseases, such that vaccine rollout is seen as the light at the end of the pandemic tunnel. For decades, the vaccine segment of the pharmaceutical industry had been regarded as a market with limited revenue opportunities. However, these myths have been dispelled by novel, high-price products such as Prevnar and Gardasil, illustrating that vaccines have commercial potential with the right strategies in place.

Gardasil, an exceptionally successful example, achieved blockbuster status soon after its market debut. In 2019 alone, Gardasil generated $3.7 billion in revenue (1).

Developed by Merck, Gardasil was the first human papillomavirus (HPV) vaccine to be granted regulatory approval by EMA and the FDA in 2006 (2,3). This approval represented a significant breakthrough in women’s health considering the association with cervical cancer secondary to HPV infection. Gardasil is a quadrivalent recombinant vaccine that spurs production of antibodies against HPV subtypes 16 and 18, which cause approximately 70% of HPV-related cervical cancer cases, and subtypes 6 and 11, which cause about 90% of genital wart cases (4).

In 2015, Merck received regulatory approval for its 9-valent Gardasil vaccine, which includes 5 additional HPV strains (5). The vaccine is widely known as Gardasil 9.

The Gardasil case could potentially offer several lessons for future vaccine launches.

Merck primed the market prior to launch by establishing the link between HPV and cervical cancer through several campaigns such as “Tell Someone”, “One Less”, or “Make the Connection”. By creating awareness amongst healthcare professionals, governments, and the public and simultaneously steering clear of cultural taboos, Merck positioned Gardasil as a cancer vaccine rather than an STD vaccine. This strategy was effective in the early generation of disease burden data, clearly demonstrating the substantial burden of cervical cancer on women and healthcare systems. With such momentum built prior to its regulatory approval in Europe, it received a positive recommendation by all EU5 National Immunization Technical Advisory Groups (NITAGs) within one year of regulatory approval – a considerably shorter time compared with other vaccines launched within the last two decades. (Bexsero was recommended after 3 years, while Zostavax was recommended after 5 years)

Gardasil is one of the most expensive vaccines on the market. Its relatively high price was driven by the vaccine characteristics and value it offers, alongside a robust pricing strategy that encompassed capturing and anticipating health impacts and economic saving. Moreover, Gardasil has a remarkable efficacy of 100% for prevention of HPV vaccine type-related persistent infection. However, it was the protection against genital warts which represented a key differentiating factor against its competitor Cervarix, making Gardasil the preferred product to be reimbursed by payers, so much that in the US, Cervarix was discontinued from the market in 2016.

 

Merck collaborated with universities and research centres to publish cost-effectiveness analyses up to 3 years prior to regulatory approval in order to demonstrate the reduction of burden of disease and the estimation of the monetary savings. Complex modelling was required due to both the long and uncertain time to cancer development (20‒30 years) and the inability to quantify healthcare expenditure reductions in the near future.

Another reason for the enhancement of the cost-effectiveness of Gardasil was the inclusion of genital warts prevention. Since prior to Gardasil’s launch the economic impact of genital warts was scarce, Merck commissioned health economic consultancies to generate the required evidence.

Finally, Merck engaged with key stakeholders in order to secure public acceptance and widespread vaccine uptake. In the UK for example, the Department of Health commissioned work on knowledge and public attitudes about cervical cancer, HPV and vaccination. The study looked at the parental responses to the introduction of a vaccine against HPV. The work demonstrated that parents were generally very positive about a vaccine to prevent cervical cancer. A crucial factor of these attitudinal studies is that they were not company led, which helped build public confidence on the vaccine safety and efficacy.

Conclusively, by generating the appropriate evidence prior to NITAG evaluation and employing the right stakeholder engagement and pricing strategy, higher priced vaccines such as Gardasil have reshaped a market with historically low margins. The strategies employed by Merck could potentially be leveraged by other vaccines in the pipeline to spur another wave of double-digit growth in the future.

 

Related Links

  1. https://www.spglobal.com/ratings/en/research/articles/200803-covid-19-may-accelerate-disruption-in-the-global-vaccine-market-11568238
  2. https://www.ema.europa.eu/en/documents/product-information/gardasil-epar-product-information_en.pdf
  3. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/gardasil-vaccine-safety#:~:text=FDA%20approved%20Gardasil%20on%20June,HPV%20types%206%20and%2011.
  4. Braaten KP, Laufer MR. Human Papillomavirus (HPV), HPV-Related Disease, and the HPV Vaccine. Rev Obstet Gynecol. 2008;1(1):2-10.
  5. https://www.ema.europa.eu/en/documents/variation-report/gardasil-9-h-c-3852-p46-0008-epar-assessment-report_en.pdf

 

About the author

Jona is a UK qualified pharmacist, registered with the General Pharmaceutical Council (GPhC). She holds an MPhil in Management from the University of Cambridge. Jona has extensive experience in the healthcare sector gained through several UK NHS Trusts and rotations within pharmaceutical companies. Jona has transferred her expertise to Consulting with Access Infinity.

Categories
News

Access Infinity announces the opening of new offices in Hyderabad, India as it looks to expand its presence in APAC

January  5, 2022 Hyderabad, India: Access Infinity Ltd, a leading UK Market Access Consulting and Digital Solutions provider, announced that it has expanded offices to Hyderabad, India. This expansion is concurrent with Access Infinity’s growth in the UK and the US, where its team size has doubled in the last 18 months.  

With the new opening of the India office, Access Infinity will provide better services to APAC clients in their local time zone. This news marks a pivotal moment for Access Infinity as the company doubles down on its commitment to accelerate and expand global consulting and engineering capabilities across the United Kingdom, Asia, and USA.  

“We are seeing significant interest in our products and consulting services and to support this ever-increasing demand, we are ramping up our team in India and the US. We have also made some senior leadership hirings with Sriram Iyer, a Cognizant veteran, joining us as the Head of Engineering and Shravani Madishetti, ex-Novartis, joining us as the APAC Nuro Data Lead. 

 

 

Hyderabad has emerged as one of India’s most dynamic cities due to its strong talent for software engineering and life sciences. While this is our first physical office in India, Access Infinity has had Indian employees working remotely for several years. We now have aggressive expansion plans and expect to recruit over 20 people in engineering and market access to our team over the next 12 months,”  

 – Keshav Nagaraja, Managing Director, Digital of Access Infinity 

 

 About Access Infinity: 

Access Infinity is a specialist consultancy and digital solutions provider headquartered in London. They combine business intelligence data and human expertise to help market access professionals find better insights, faster, through their consulting and next-generation digital tools. With world-leading expertise in Market Access, Pricing and Reimbursement consulting, Access Infinity focuses on delivering innovative cloud-based platforms to its clients to ensure that they can make decisions faster.  

 

Contacts: 

Cloe Carey 

Email : [email protected] 

Tel :  +44 (0) 207 078 7643

Copyright All Rights Reserved
Access Infinity 2020

Get in touch

[email protected]

LABS House,
15-19 Bloomsbury Way,
London
WC1A 2TH

Consulting

Pricing and launch strategy
Evidence gap analysis
Multi-indication price optimisation
Fast due diligence
Analogue analysis
Revenue optimisation

Products

Nuro
Access Hub
Evidence Library

Resources Blogs
About us Company information Leadership Events News
Copyright Notice | Terms of Use | Privacy Policy