Impact of Healthcare Regulations that are Centered on Health Outcomes on Pharmaceutical Companies

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The study is about European nation’s healthcare regulations that are centered on health outcomes and Implications on changes pharma companies will need to bring in their strategy and operations

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Impact of Healthcare Regulations that are Centered on Health Outcomes on Pharmaceutical Companies

  1. 2. Introduction Engaging Patients Informed, Activated Patients Transformed Healthcare Improved Health Outcomes Improving Healthcare Delivery Motivated & Prepared Practices Supportive Insurance Aligning Finance/Insurance UK, France & Germany – Healthcare Regulations <ul><li>Regulations for Improving Quality of Care and Prepared Practices </li></ul><ul><li>Regulations for Improving Affordability to Healthcare </li></ul><ul><li>Impact of Regulations on Pharmaceutical Companies </li></ul><ul><li>Key Takeaways and Solutions for the Pharmaceutical Companies </li></ul>Scope <ul><li>Geography: UK, Germany & France </li></ul><ul><li>Regulations </li></ul><ul><li>- Quality of care & prepared practices </li></ul><ul><li>- Affordability to healthcare (pricing & reimbursement) </li></ul>
  2. 3. Regulations for Improving Quality of Care UK Germany France <ul><li>HPST law caters to develop the governance of the healthcare system by bringing the state services and health insurance services together and combining the ambulatory and hospital sectors </li></ul><ul><li>The French national authority for health (HAS) to integrate a variety of activities to develop the quality of patient care and to guarantee equity within the healthcare system under a single roof </li></ul><ul><li>Healthcare spending is likely to increase in France for the next few years </li></ul><ul><li>Progress with integrated healthcare initiatives is projected to remain fairly slow </li></ul><ul><li>Hospital chains & alliances will become significantly important for an improved care </li></ul><ul><li>Hospital Financing Reform Act ( KHRG) primarily finalized the introduction of standardized diagnosis-related groups (DRGs) </li></ul><ul><li>The new government is not likely to legislate for new prescribing controls </li></ul><ul><li>Federal Joint Committee (G-BA) plans to construct disease management guidelines for almost all chronic diseases </li></ul><ul><li>Healthcare spending is likely to become stable in Germany for the next few years </li></ul><ul><li>Access to health check-ups expansion, screening and preventative vaccines improvement(Disease Prevention Measure) </li></ul><ul><li>Prescription practice is largely incorporated across primary and secondary care, influenced by the activities of Area Prescribing Committees (APCs) and exploiting joint formularies </li></ul><ul><li>The Quality and Outcomes Framework (QOF) was introduced to determine GP practice achievement against a series of evidence-based clinical indicators and also indicators covering practice organization and management </li></ul><ul><li>Healthcare spending in UK is likely to increase for the next five years </li></ul>
  3. 4. Regulations for Improving Affordability to Healthcare <ul><li>Price cuts: 1.9% in January 2010 and 3.9% in February 2009 under the revised Pharmaceutical Price Regulation Scheme (PPRS) </li></ul><ul><li>Flexible Pricing: ‘Value-based’ approach </li></ul><ul><li>Patient Access Schemes: Finance & Outcome based </li></ul>UK Germany France <ul><li>Decrease in average UK branded drug prices </li></ul><ul><li>Pharmaceutical companies say it is unattractive to conduct business </li></ul><ul><li>More rigorous price control system will be developed in the future </li></ul><ul><li>Rebate contracts will become further validated as a means for sickness funds to take advantage of higher discounts </li></ul><ul><li>Controlling prices in the patented market segment will continue to be the most important objective of policy makers </li></ul><ul><li>Cost-effectiveness estimation </li></ul><ul><li>Introduction of reimbursement approval before marketing approval </li></ul><ul><li>Pharmaceutical Companies are skeptical about the price cuts/freeze </li></ul><ul><li>Drugs are priced high at the launch </li></ul><ul><li>Regular price reductions and ad hoc price cuts (CEPS) </li></ul><ul><li>Clinical advantage rating of a drug (ASMR Rating) </li></ul><ul><li>Newly-developed committee within the HAS will assess the medico-economic contributions of product classes </li></ul><ul><li>All products having a therapeutic effect are reimbursed </li></ul><ul><li>Slowdown in the number of innovative drugs reaching the market </li></ul><ul><li>Intensive clinical benefit rating system </li></ul>Net Effect on Pharmaceutical Companies ( + ) ( - ) ( - )
  4. 5. Impact of Regulations on Pharmaceutical Companies in UK 1- 2 years 3- 4 years 4-5 years UK Factors <ul><li>Policies on Price cuts </li></ul><ul><li>Allowed price modulation within the product range </li></ul><ul><li>Patient access schemes </li></ul><ul><li>Healthcare Funding to increase for the next five years </li></ul>High Impact Medium Impact Low Impact Drivers Restraints <ul><li>Key Takeaway: </li></ul><ul><li>The market is highly regulated and pharmaceutical companies will not have any control over the situation </li></ul><ul><li>Required Amendments: </li></ul><ul><li>P harmaceutical companies should form collaborations or provide help in areas such as support for practices with bidding or tendering processes </li></ul><ul><li>Spending on hospital prescribing is exceeding primary care and hence pharmaceutical companies should remain focused on hospital markets </li></ul><ul><li>Work with GP practices to help them meet the requirements of the QOF </li></ul><ul><li>Patient Compliance: Increase joint venture program with the pharmacies & build up pharmacy based patient support programs </li></ul><ul><li>Focus more on the KAM model </li></ul>
  5. 6. Impact of Regulations on Pharmaceutical Companies in Germany 1- 2 years 3- 4 years 4-5 years Germany Factors High Impact Medium Impact Low Impact Drivers Restraints <ul><li>Cost effectiveness assessments </li></ul><ul><li>Controlling prices of the patented drugs </li></ul><ul><li>Government is unlikely to legislate for new prescribing controls </li></ul><ul><li>Healthcare funding to increase for the next five years </li></ul><ul><li>Key Takeaway: </li></ul><ul><li>Pharmaceutical companies are positive about the government & their supportive regulatory guidelines </li></ul><ul><li>Required Amendments: </li></ul><ul><li>Invest on analytics: For performing cost-benefit assessments & health outcomes of the pipeline drugs for quicker approvals </li></ul><ul><li>Pharmaceutical companies have to realign their sales and marketing strategies (declining influence of physicians on prescribing procedures) </li></ul><ul><li>Introduce key account management-based selling </li></ul><ul><li>Business friendly environment: Pharmaceutical companies should capitalize upon the environment to boost their R&D in Germany </li></ul>
  6. 7. Impact of Regulations on Pharmaceutical Companies in France 1- 2 years 3- 4 years 4-5 years France Factors High Impact Medium Impact Low Impact Drivers Restraints <ul><li>Regular price reductions & ASMR rating for a drug </li></ul><ul><li>Improve the quality of patient care and the healthcare system </li></ul><ul><li>Integrating the ambulatory and hospital sectors </li></ul><ul><li>Healthcare Funding to increase for the next five years </li></ul><ul><li>Key Takeaway: </li></ul><ul><li>The market in highly regulated and pharmaceutical companies should introduce new CSR programs to stay visible </li></ul><ul><li>Required Amendments: </li></ul><ul><li>Pharmaceutical companies have to re-evaluate the role of medical rep visits (product choice will significantly be influenced by prescribing objectives and less by marketable activities) </li></ul><ul><li>Invest on analytics: For gaining high ASMR rating </li></ul><ul><li>Identify new entrants in the regional health authorities and decide how to adapt marketing plans to the new environment </li></ul><ul><li>Develop programs to bring together patients with pharmacists </li></ul>
  7. 8. <ul><li>For More Information, Contact: </li></ul><ul><li>Commercial Insights </li></ul><ul><li>support@commercialinsights.com </li></ul><ul><li>www.commercialinsights.com </li></ul>

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