Neil Grubert’s Post

Very interesting article! Over emphasis of many healthcare systems on technological advances in pharmaceutical drugs diverting scarce resources on expensive drugs, leaving population or important public health sector mostly unattended. A diming NHS is not an exception unfortunately! #Healthcareresource #drugcosts #NHS #prescriptionmedicines

Spain’s autonomous communities will have a majority position in the Health Technologies Positioning Group proposed in the recently published draft Royal Decree on HTA. César Hernández, the Director General of the Common Portfolio of SNS and Pharmacy Services, provided more detail on the likely shape of the new HTA process at the 23rd Meeting of the Spanish Pharmaceutical Industry.   The draft legislation proposes that the Office for the Evaluation of the Efficiency of Medicines will conduct separate clinical and economic evaluations of new drugs. The Health Technologies Positioning Group will then carry out final assessments based on the evaluation reports prepared by the Office as well as other relevant information—notably price proposals negotiated between the manufacturer and the Ministry of Health (tinyurl.com/phb35f48).   Hernández likened the Positioning Group to a hinge connecting the evaluation and decision-making processes, albeit with greater emphasis on the latter function. As such, he sees the Positioning Group as akin to a facilitator or preparatory committee for the Interministerial Commission on Drug Prices (CIPM), which will ultimately determine the prices of new medicines in its negotiations with pharmaceutical companies.   The autonomous communities will hold 17 of the 27 votes in the Positioning Group—one for each community. By comparison, they collectively have just three of the 11 votes in the CIPM.   Representatives of the pharmaceutical industry at the meeting expressed reservations about the influence of the autonomous communities under this new arrangement and raised the question of whether a redistribution of powers was necessary. Hernández responded that this issue was beyond the scope of the Royal Decree on HTA and emphasised the importance of “accommodating” the interests of the autonomous communities, which “must play their role” in HTA.   The Director General was open to the possibility of renaming the Positioning Group because of confusion about what “positioning” implies. He said: “We don’t want to leave reminders of IPTs [therapeutic positioning reports], which will no longer exist.” He encouraged the audience to propose alternative names for the Positioning Group, as well as other modifications to the draft Royal Decree on HTA.   The new system is intended to be flexible in nature. “Living” documents and guidelines should be easy to update.   Hernández hopes that the Royal Decree on HTA can be approved this year. With regard to other legislation to reform the Spanish access environment, he disclosed that a first draft of the revised Guarantees Law should be reviewed by the Council of Ministers before very long. A public consultation on the Royal Decree on Pricing and Reimbursement is planned before the end of the year, with the legislation due to progress through Parliament in 2025. #Spain #HTA

Effective decision-making in the choice of comparators and outcomes during clinical & economic development of a drug have long been a critical factor for successful market access. On January 12, 2025, the Health Technology Assessment (HTA) Regulation came into force, marking a major advancement in ensuring that innovative and effective health technologies reach patients across the European Union (EU). This new regulatory framework is set to transform the evaluation of new medicines and health technologies in the EU. The future of the European pharmaceutical market is on the brink of a major shift, driven by emerging trends that will undoubtedly reshape market access strategies. Anticipated regulatory changes are expected to continue refining the landscape, focusing on streamlining procedures and supporting medical innovation advancements. #HTA #MarketAccess #Drugapproval #EU #EMA #EUHTA Vikram Shanbhag For detailed insight, read the blog written by me on SG Analytics website:

📈 💊 The #NHS pharmaceutical expenditure, particularly in hospital settings, has grown faster than spending on other healthcare services. But is this allocation of money the most efficient in terms of saving lives? Huseyin Naci, Peter Murphy, Beth Woods, James Lomas, Jinru Wei and Irene Papanicolas argue that the way the National Institute for Health and Care Excellence (NICE) calculates the cost-benefit analysis for new drugs should be more transparent, taking into consideration those who will lose out due to reduced resources for other treatments.

€1bn of drug price cuts and a clawback cap maintained at €1.6bn: these are key proposals for the pharmaceutical sector in the first draft of France’s Social Security Finance Bill (PLFSS) 2025. The government also plans to change the way clawback payments are calculated. The pharmaceutical industry is disappointed that its recent proposals for an alternative package of measures (tinyurl.com/53jykym4) have been rejected.   The broad health strategy in the PLFSS 2025 will have five priorities: improving the organisation of the healthcare system, securing its funding, strengthening policies on psychiatry and mental health, making healthcare professions more attractive and supporting innovation. The government notes that “healthcare spending is rising much faster than national wealth. To ensure the sustainability of our healthcare system, and in the current budgetary context, it is still necessary to seek better control of expenditure.”   Drug price cuts are an annual phenomenon in France, linked to each year’s PLFSS. For 2025, however, the government is proposing the highest level of cuts since 2019. Leem reports that cuts averaged €900mn per year from 2012 through 2019 but declined to €600-850mn in the following years. In addition to the €1bn of price cuts, there would be €200mn of savings from lower prices on some medical devices.   The so-called “safeguard clause,” which determines the level of clawback payments if pharmaceutical expenditure exceeds growth limits, will remain at the reduced level of the €1.6bn cap implemented for 2023 and 2024. The method of calculating spending that counts towards the safeguard clause will be revised: it will be based on reimbursed amounts rather than sales. The government believes this change will lighten the administrative burden on companies and make clawback calculations more predictable.   Leem had called on the government to reduce clawback payments to €1bn in 2025, €750mn in 2026 and €500mn in 2027. This trajectory would require additional funding of €1.1bn in 2025, €2.1bn in 2026 and €3.1bn in 2027. In the association’s view, “we must also stop the excessive race to lower prices.” A new prescribing support system introduced in the previous PLFSS to promote the appropriate use of medicines will be extended. Prescribers will be notified immediately if a prescription is deemed inappropriate—in which event, reimbursement will be denied.   In response to the government’s proposals, Leem’s President, Thierry Hulot, said: “Focusing efforts on further price cuts will further weaken companies in their health mission. This is all the more regrettable since for months we have been proposing €1bn in savings on concrete measures. There is therefore room to improve this PLFSS without impacting public spending. If we want to preserve French people's access to their treatments and strengthen the health sovereignty of our country, it is urgent to make the right choices!” #France #PLFSS #costcontainment #clawbacks

📢 Interesting findings from a recent study published in Health Affairs conducted by researchers at the University of Southern California (USC) Schaeffer Center! The study focused on Medicare Part D plans and their impact on prescription drug utilization restrictions from 2011 to 2020. The results are in, and it seems that Medicare Part D plans have significantly increased their utilization restrictions over the past decade. The study found that the average percentage of restricted compounds in these plans rose from 31.9% in 2011 to a whopping 44.7% in 2020. Notable among these restrictions were formulary exclusions, with an average of 44.7% of brand-name-only compounds being excluded from plan formularies. Utilization was further restricted through measures like prior authorization and step therapy requirements. Interestingly, the study also found that these restrictions were more prevalent among brand-name-only compounds, more expensive drugs, and in stand-alone Part D plans compared to Medicare Advantage prescription drug plans. While drug utilization management tools can be effective in ensuring cost-effective prescribing, the study authors raised concerns about the potential negative impact on patient adherence and health outcomes. The authors suggest that further research is needed to better understand these implications. Unsurprisingly, the findings have sparked a reaction from industry stakeholders. The Pharmaceutical Research and Manufacturers of America (PhRMA) commented on the study, emphasizing the need to protect seniors' access to treatments. They believe that Congress must address abuses of the program and require pharmacy benefit managers (PBMs) to share rebates with seniors at the pharmacy. The study sheds light on an important aspect of our healthcare system and calls for further exploration. Let's continue to advocate for the well-being of Medicare Part D beneficiaries and work towards a more accessible and affordable prescription drug landscape. #MedicarePartD #PrescriptionDrugUtilization #PatientAccess

🚨 Transformative Changes in Turkey's Pharmaceutical Reimbursement Landscape! 🚨 by Oznur Seyhun The recent updates to the Sağlık Uygulama Tebliği (SUT) mark a pivotal moment for healthcare in Turkiye. These amendments are set to enhance system efficiency, improve patient access, and foster innovation. ✨ Key Highlights: - Elimination of 30% Discount: Encourages access to groundbreaking biological medicines! 💊 - Flexible Internal Reference Pricing: Aligns pricing with market dynamics for a fairer structure. ⚖️ - Streamlined Application Timelines: Predictable schedules for reimbursement applications boost collaboration! 📅 - Annual Evaluation of Non-Marketed Products: Ensures relevance and accuracy in pricing calculations, reducing out-of-pocket costs for patients. 💰 These changes reflect a commitment to modernizing the pharmaceutical landscape while balancing patient needs with market adaptability. 📈 Stakeholders must adapt their strategies to seize opportunities presented by these reforms! For an in-depth analysis of these significant updates and their implications, click on the link below! #Healthcare #HealthcarePolicyandRegulation #Innovation #Organon #OtsukaHoldings #PaciraPharmaceuticals #Perrigo #PharmaMar #Pharmaceuticals #PharmingGroup #Photocure #PliantTherapeutic #PolyPeptide #PrestigeConsumerHealthcare #SGK #SUTUpdates #Turkiye #MarketAccess #MarketAccessToday

Are Doctors' Fraternity Responsible for Higher Pricing of Medicines, Making Healthcare Unaffordable for the Poor? The rising cost of healthcare is a pressing issue that affects millions, particularly low-income families. A significant component of this crisis is the pricing of medicines, which raises the question: are doctors to blame for these soaring costs? Recent studies indicate that in many cases, the prices of essential drugs have increased dramatically. According to the World Health Organization (WHO), the price of essential medicines can vary by up to 1,000% between different countries. In India, for example, the cost of life-saving medications has surged, often leaving low-income patients unable to afford necessary treatments. One might argue that doctors contribute to this problem by prescribing expensive brand-name medications over generic alternatives. A study by the National Pharmaceutical Pricing Authority (NPPA) found that in India, nearly 70% of the prescribed medicines are branded, which can be significantly more costly than their generic counterparts. However, it's essential to consider the doctors' perspective; many physicians prescribe what they believe is the most effective treatment for their patients, often based on pharmaceutical marketing and their experiences. Moreover, the pharmaceutical industry plays a crucial role in drug pricing. According to the Indian Pharmaceutical Alliance, around 12% of drug costs go towards marketing and promotions. This promotional expenditure can influence prescribing habits and contribute to higher prices. While doctors are part of the healthcare ecosystem, they are not solely responsible for the rising medicine costs. The interplay of pharmaceutical companies, government regulations, and the healthcare system as a whole must be examined. To address this issue, a multifaceted approach is required, including better education for healthcare professionals on the cost-effectiveness of treatments, enhanced access to generic medications, and stricter regulations on drug pricing. In conclusion, while the doctors' fraternity plays a role in the healthcare pricing structure, they are not the root cause of the issue. A collaborative effort involving all stakeholders in the healthcare system is essential to ensure that quality healthcare remains accessible to everyone, especially the underprivileged. #HealthcareForAll #AffordableMedicine #HealthEquity #DoctorsAndPharma

Spain’s long-awaited Royal Decree on the Pricing and Reimbursement of Medicines has been released in draft form for public consultation until 15th January 2025. The text notes that “it is necessary for the drug funding and pricing system to focus on the entire life cycle of the drug and not exclusively on the initial decisions. This requires an ‘ex post’ evaluation of the application of the pricing and public reimbursement systems and their results, based on information systems that provide relevant information to verify their adjustment to the policies previously defined by the competent bodies.”   The text identifies 13 objectives:   1) Regulate and define P&R methods and procedures, as well as all the criteria that must be used, regardless of whether they involve new products, new indications or adjustments. The criteria for exceptional reimbursement restrictions or exclusions should also be included.   2) Establish procedures and conditions for accelerated, conditional and provisional funding authorisations, developing a system of pricing and associated payment and compensation, if applicable, as well as the application of new payment models when appropriate.   3) Establish procedures to complement the generation of knowledge on how the drug works in real life in areas where uncertainty exists, as well as entry and exit conditions.   4) Determine the criteria for developing guidelines and evaluation procedures, with clear and transparent rules.   5) Establish the framework for health economic evaluation and budget impact analysis to comply with the efficiency criterion. All of this should take account of financial uncertainty.   6) Modify the reference pricing system by introducing elements that increase competition and value incremental benefit.   7) Reform the procedures for the listing and pricing of generics and biosimilars.   8) Establish and define the framework for the relationship of the persons and groups directly or indirectly involved in decision making related to the funding and pricing of medicines, including persons from the administration, patients, consumers, healthcare professionals and health economists.   9) Systematise the application situations and existing channels for early interaction between companies and the health administration.   10) Establish and define which exceptions could be applicable to the regular procedures (e.g., drugs that meet certain needs of patients or groups of patients, drugs used in public health campaigns, among others).   11) Establish mechanisms for monitoring and basic rules for the revision of prices for those products that already have a positive funding decision.   12) Define procedures to ensure transparency in reporting, as well as the confidentiality of aspects that should be confidential.   13) Establish the procedures and systems for communicating to the Ministry of Health the information necessary for the follow-up of P&R decisions. #Spain #drugpricing #reimbursement

Looking ahead, the resolution of the 340B program's challenges will likely require compromise among various stakeholders. Future solutions may involve finding middle ground between manufacturers, covered entities, and policymakers to ensure program sustainability. This could include clearer guidelines on program participation, more robust oversight mechanisms, and potentially a redefinition of patient eligibility criteria. The impact of these challenges and potential reforms extends beyond policy considerations to directly affect pharmacy practice. Pharmacies, particularly those serving as contract pharmacies for 340B entities, face increased administrative burdens in tracking 340B eligibility and managing multiple inventories. Impending legislation could potentially make this problem worse if not correctly implemented. The uncertainty surrounding the program's future may impact long-term planning and resource allocation for many pharmacies who have not only supported the program over the years but possibly relied on it. As the 340B Drug Pricing Program stands at this critical juncture, it's clear that the decisions made in the coming years will shape not only the future of the program itself but also its impact on health care access for vulnerable populations and the broader landscape of pharmaceutical pricing in the United States. Balancing program integrity with the original mission of supporting vulnerable populations remains crucial as stakeholders debate the program's future. The resolution of current challenges will significantly influence the role of 340B in America's health care system and its impact on pharmacy practice for years to come. #pharmacy #340B #healthcare https://lnkd.in/egyKZ7kM