Arnaud Lavenue’s Post

Drug pricing and reimbursement method in Singapore - Role of ACE <<<<<Information useful for HEOR/RWE and Market Access professionals>>>>> Here are certain key points regarding HTA assessment: ***ACE has 4 departments and 3 advisory councils to support the whole process ***4 departments are: HTA (HTA assessment and recommendation MOH DAC committee for negotiations with manufacturers), CEE (for Patient education), ETPO (for developing Clinical guidance), and P&P (for Strategic planning, administration, and finance) ***3 Advisory panels: ACE council, IPA Council, and ACE consumer panel  In addition to HTA assessment, ACE also does Horizon scanning, which is a systematic identification of new and emerging technologies or technologies that are becoming obsolete that have potential to affect the health of the society. Horizon scanning does not have any funding implications >>>Type of HTA recommendations (Refer to the attached screenshot) >>>HTA technologies assessed so far: https://lnkd.in/dHXDnZAu >>>HTA assessment methods and ongoing assessments here: https://lnkd.in/d8nB7DES >>>Major insurance providers include MediSave, MediShield, MediFund (For those unable to pay), ElderShiled (>40 years) >>>There are 2 types of reimbursement: Standard Drug list (SDL) and Medication Assistance fund (MAF, came in 2010) <<<% reimbursement under SDL>>> (https://lnkd.in/ddjp2dvz)  75% if PCHI <2K $ 50% if PCHI >2K $ <<<% reimbursement under MAF>>> 75% if PCHI <2K $ 50% if from 2K $ to 3300$ 40% if from 3300 $ to 6500$ 30% if >6500 $ >>>List of drugs with the reimbursement category given here: Subsidy list with types: https://lnkd.in/dCzHTxdx  >>>The current drug prices are listed here: Drug prices: https://lnkd.in/dWDtnhDP Timeline - <<Types of HTA assessments 1. Full evaluation: 3 to 9 months depending on the complexity of the topic and the number of existing approved technologies 2. Expedited approval: 2 to 3 months  3. Value based pricing <<<<<<CEA Analysis points>>> Current there is well defined cost-effectiveness threshold value, however 0.7 times the Singapore GDP per capita can be used for the basic purposes Like most the global HTA agencies, there are 3 steps in the evaluation process: 1. Topic selection and prioritisation 2. HTA submission and evaluation  3. Decision making and guidance development For more detail refer to the attached document. #healtheconomics #healthoutcomes #healthtechnologyassessment #hta #heor #drugpricing #marketaccess #oncology #drugdevelopment #pharmaceuticalindustry #biopharma #realworldevidence #rwe #costeffectiveness #reimbursement

Drug pricing and reimbursement method in Singapore - Role of ACE <<<<<Information useful for HEOR/RWE and Market Access professionals>>>>> Here are certain key points regarding HTA assessment: ***ACE has 4 departments and 3 advisory councils to support the whole process ***4 departments are: HTA (HTA assessment and recommendation MOH DAC committee for negotiations with manufacturers), CEE (for Patient education), ETPO (for developing Clinical guidance), and P&P (for Strategic planning, administration, and finance) ***3 Advisory panels: ACE council, IPA Council, and ACE consumer panel  In addition to HTA assessment, ACE also does Horizon scanning, which is a systematic identification of new and emerging technologies or technologies that are becoming obsolete that have potential to affect the health of the society. Horizon scanning does not have any funding implications >>>Type of HTA recommendations (Refer to the attached screenshot) >>>HTA technologies assessed so far: https://lnkd.in/dHXDnZAu >>>HTA assessment methods and ongoing assessments here: https://lnkd.in/d8nB7DES >>>Major insurance providers include MediSave, MediShield, MediFund (For those unable to pay), ElderShiled (>40 years) >>>There are 2 types of reimbursement: Standard Drug list (SDL) and Medication Assistance fund (MAF, came in 2010) <<<% reimbursement under SDL>>> (https://lnkd.in/ddjp2dvz)  75% if PCHI <2K $ 50% if PCHI >2K $ <<<% reimbursement under MAF>>> 75% if PCHI <2K $ 50% if from 2K $ to 3300$ 40% if from 3300 $ to 6500$ 30% if >6500 $ >>>List of drugs with the reimbursement category given here: Subsidy list with types: https://lnkd.in/dCzHTxdx  >>>The current drug prices are listed here: Drug prices: https://lnkd.in/dWDtnhDP Timeline - <<Types of HTA assessments 1. Full evaluation: 3 to 9 months depending on the complexity of the topic and the number of existing approved technologies 2. Expedited approval: 2 to 3 months  3. Value based pricing <<<<<<CEA Analysis points>>> Current there is well defined cost-effectiveness threshold value, however 0.7 times the Singapore GDP per capita can be used for the basic purposes Like most the global HTA agencies, there are 3 steps in the evaluation process: 1. Topic selection and prioritisation 2. HTA submission and evaluation  3. Decision making and guidance development For more detail refer to the attached document. #healtheconomics #healthoutcomes #healthtechnologyassessment #hta #heor #drugpricing #marketaccess #oncology #drugdevelopment #pharmaceuticalindustry #biopharma #realworldevidence #rwe #costeffectiveness #reimbursement

PBAC Reviews Endometriosis Treatments for PBS Inclusion, Aiming to Bridge Healthcare Gaps in Australia The Pharmaceutical Benefits Scheme (PBS) review in Australia is examining medication accessibility for individuals with endometriosis. The review aims to expand access to essential treatments and improve healthcare equity for those affected by the condition. The Australian government has allocated $58 million for endometriosis treatment and research as part of the National Action Plan for Endometriosis. The report identified medicines currently listed on the PBS for endometriosis treatment and proposed additional options. Barriers to accessing treatments include limited training among healthcare professionals and a lack of incentive for pharmaceutical companies to pursue PBS listing. The PBAC has acknowledged the need for funding more medicines but also highlighted the need for further research to evaluate the effectiveness of suggested treatments. For more details please click the link! https://lnkd.in/dAZZDuib #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Medication nonadherence is a problem that belongs to nobody. This is a powerful statement by Przemyslaw Kardas in a review article in the January 2024 issue of the European Journal of Internal Medicine. The author argues that no stakeholder across the healthcare spectrum - including doctors, nurses, pharmacists, and patients - is willing to take responsibility for the festering problem that results in significant loss of revenue to pharmaceutical companies. 1️⃣ Does this statement have any credence? In an era where we are witnessing a race to develop new drugs and where technological breakthroughs such as AI are being deployed to accelerate drug discovery, it may be more worthwhile to revisit strategies to improve adherence. If developing new medicines is about saving lives, it is worth noting that a staggering 275,000 patients die globally each year due to nonadherence. 2️⃣ Promoting medication adherence could also be more cost-effective than bringing new medicines to the market. This one is a no-brainer for the healthcare industry as a whole since billions of dollars that need to be invested across the drug discovery, development, pre-clinical testing, clinical trials, marketing, distribution and post-market surveillance could be saved by simply focusing on improving adherence to available therapies, especially in chronic diseases. 3️⃣ But medication nonadherence is not a simple problem to solve. No doubt about this, but research and health economics data indicates it is worth solving. A 2018 study by Prime Therapeutics that evaluated claims data of 300,000 patients enrolled in Medicare Advantage plans in the US found that "moving someone with low adherence (<50%) to near perfect adherence (99%+) was associated with potential total cost of care savings of * $3,365 potential savings per patient per year for diabetes medications * $2,901 potential savings per person per year for hypertension medications * $1,563 potential savings per person per year for cholesterol medications 4️⃣ Is there any universal approach? Promoting medication adherence as a part of brand management strategy could result in recovering millions of lost revenues for pharma companies. Effective brand planning should consider unmet patient needs and tailor interventions to address these gaps. There is a need to evaluate approaches beyond patient support or access programs and technological innovations including digital health offer an unprecedented opportunity for pharma marketers. Medication nonadherence can significantly undermine pharmaceutical innovation. Improving adherence to treatment, especially in chronic conditions, has direct implications for society, healthcare systems as well as revenue and profits. #medicationadherence #healtheconomics #innovation #drugdiscovery #aiinhealthcare #digitalhealth

Drug pricing: The devil lurks behind the door A number of basic levers are missing to date in CMS guidance, so can CMS create, borrow or just use the results of say another countries calculations? A recent study (Egilman et al) found that many top prescribed Medicare drugs have low benefit ratings from HTA agencies, and this information could be helpful for the future, say on evaluating therapeutic alternatives. A recent opinion piece (below link) deftly evaluates the issue. “For Apixaban, one of the reasons given by the French HTA body was that randomised trial comparisons between Apixaban and Rivoroxaban or Dabigatran were lacking. At the time of initiation of the pivotal Apixaban trial, Rivoroxaban or Dabigatran were not approved treatments and therefore this is not an issue of trial design. We now however have a wealth of post-approval studies examining this question with real-world data, with a consistent finding of a safety benefit of Apixaban as compared with other direct oral anticoagulants”. True, CMS experts in pharmacy economics could spend the next year or two evaluating all the studies, just on that mentioned product and reading the background methodologies cited in the studies. You can see why perhaps Merck in their law suit said a fee schedule might be better. The authors conclude “that while (Egilman et al) suggest that their data may be beneficial for pricing negotiations as part of the Inflation Reduction Act, we would caution that this should only be done after understanding the challenges of HTA, making sure the values of the United States are incorporated in any assessment ”. But, timing remains a problem, I am unsure how CMS meets its stated goal of reviewing the sum total of all research in a year, much less rebakes them in a U.S. shaped cake pan. (And how can CMS review the studies without incorporating by inference QALY model estimates. By the time of the revised guidance, you can see that perhaps CMS is realizing how impossible it is to completely avoid.) I encourage others to FOIA (or at least try) CMS’ conversations with outside experts on methods; outside consults on data and methodology are not listed; nor will these data potentially be reported to the public. To me, the Egilman article did not convey the complexity behind the HTA decisions on therapeutic alternatives. Comment: the authors below give a fuzzy rationale for PFS in HTAs, which plays a role in negative ratings of new cancer products in the EU. I argue PFS is acceptable, because patients progress from one line to another, rather than terminate treatment and progress thereafter to death. Comment: A pet peeve is people who don’t read the studies or cases that they cite all the way through, much less understand what they are citing. I read, perhaps swayed by the catchy finding that met some of my beliefs on low-value products, but ignored my own knowledge when I read the Egilman article, mea culpa. #ira #drugpricing

🌟Ardelyx's, Xphozah (tenapanor), has earned the coveted #orphandrug designation from the US Food and Drug Administration for the treatment of paediatric hyperphosphatemia. 🏆 Originally approved last month as an add-on therapy for adult chronic kidney disease patients on dialysis, Xphozah is an oral phosphate absorption inhibitor. Its #innovative mechanism involves inhibiting the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway—the primary route of phosphate absorption. 👉 Key Achievements: ✨ Tax Credits and Market Exclusivity: With this designation, #Ardelyx is set to receive tax credits for US-based clinical trials and, upon approval, potentially enjoy seven years of market exclusivity specifically in the #paediatric hyperphosphatemia domain. This recognition reflects the FDA's acknowledgment of Xphozah's potential impact on improving the lives of young patients. 🌊 Addressing Hyperphosphatemia Challenges: #Hyperphosphatemia, characterized by elevated phosphate levels in the blood, poses significant challenges for patients with chronic kidney disease. Ardelyx's Xphozah provides a crucial solution, especially for those unresponsive or intolerant to conventional phosphate binder therapy. 📈 Next Steps: As Ardelyx moves forward with Xphozah's potential application in paediatric hyperphosphatemia, the focus remains on advancing #clinicaltrials and contributing to the evolving landscape of therapeutic options for young patients. The recognition by the #fda not only signifies a significant step for Ardelyx but also reinforces the #commitment to addressing unmet medical needs on a global scale. #ArdelyxInnovation #FDAApproval #PediatricHyperphosphatemia #MedicalAdvancements #HealthcareTransformation #SymmetricTraining

The healthcare and pharmaceutical landscape witnessed significant shifts recently, impacting Nigeria’s position in the global market and its efforts towards accessible healthcare. First, NAFDAC’s recall of the Benylin Pediatrics syrup, manufactured by Johnson & Johnson, highlighted the agency’s commitment to ensuring drug safety and quality, prompting action across Africa’s pharmaceutical regulators. Simultaneously, Nigeria achieved a milestone by becoming the first country to roll out the Men5CV vaccine, recommended by the World Health Organization (WHO), offering broader protection against meningococcal bacteria. Additionally, President Bola Ahmed Tinubu’s approval of the National Health Fellows Program demonstrates the government’s dedication to enhancing primary healthcare across the nation. In conclusion, these recent developments underscore Nigeria’s commitment to advancing its healthcare and pharmaceutical sector. By prioritizing safety, accessibility, and innovation, Nigeria aims to sustain progress and address emerging challenges, fostering collaboration between government agencies, regulatory bodies, and industry stakeholders for a healthier nation. Click the video for a breakdown of recent developments in the Health and Pharmaceutical Sector, as well as their impact and outlook. #strenandblanpartners #commerciallawfirm #healthsector

Did you see the Important News for Valproate-containing medicines? Big changes are happening in the world of pharmaceuticals! Starting October 11, 2023, valproate-containing medicines will be dispensed in their original packaging. What does this mean? Patients will always get vital safety info with their prescription, ensuring a safer experience for all. This is a significant step towards minimizing risks for women and their unborn babies. It's proof that the pharmaceutical industry is always evolving to prioritize patient well-being. 💊💡 #PharmaUpdates #MedicationSafety #PatientCare #Innovation #medical #technology https://lnkd.in/dewX62cQ https://lnkd.in/dJpgiuPd

World Health Organisation (WHO) India Country Office along with the Translational Health Science & Technology Institute (THSTI), Government of India in collaboration with the Pharmacy Council of India (PCI) have co-developed and launched an e-learning course on the Rational use of medicines for pharmacists. Appropriate use of medicines is a key factor in achieving Universal health coverage WHO defines rational use of Medicines (RUM) as "patients receiving medications appropriate to their clinical needs, in doses that meet their requirements, for an adequate time, and at the lowest cost to them and their community". Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), Central Drugs Standard Control Organisation Govt of India highlighted during his Inaugural Address "I firmly advocate that the rational use of medicines is pivotal in preventing avoidable adverse drug effects, optimising therapeutic outcomes by fostering patient adherence, and minimising the overall expenditure on drug therapy. The Govt of India through the National Health Policy (2017) emphasises the importance of rational use of medicines including pharmacovigilance in healthcare settings. Congratulating THSTI, PCI, and WHO India Office, for the launch of the e-learning course on rational use of Medicines, Dr Roderico H Ofrin, WHO Representative to India said, "I am certain this course will enhance the knowledge of pharmacists in the promotion of rational use of medicines across healthcare delivery system in the nation and ultimately contribute to providing quality health care to patients." WHO recommends strategies to promote rational use of medicines which includes drug use policies, clinical guidelines and evidence-based clinical practice, essential medicines list, public education about medicines, and appropriate and enforced regulation. "This online course has several unique features like inbuilt mechanism for an exit assessment and certification and dynamic discussion forum for continued interaction between the experts & participants," said Dr Hilde, Team Leader, Health systems, WHO India Country office. In his Keynote Address, Dr G Karthikeyan, Executive Director, BRICS-Translational Health Science and Technology Institute, Department of Biotechnology, Government of India emphasised that "This course aims to deepen understanding and promote compliance with rational medication practices within the healthcare system. By ensuring patients receive appropriate medications in optimal doses and duration at minimal cost, pharmacists play a pivotal role in enhancing health care.

💊 "Pharmacist-led common ailment schemes: a FIP Global Intelligence Report" is out now! Rúben Viegas and I are proud co-authors of this report, with Gonçalo Sousa Pinto as an editor.📘 https://lnkd.in/g2WPiSUj 📢Highlights from today's launch event: #Pharmacists play an integral role in reducing GP visits and ED presentations by effectively triaging and providing expert consultations for common ailments, leading to improved health and economic outcomes. 🔹 Expertise Recognition: it is crucial that pharmacists are formally acknowledged for their specialised #expertise in managing minor conditions. 🔹 Structured Inclusion: Pharmacists should be part of structured prescribing schemes, collaborating with other health professionals for a cohesive integration in primary healthcare. 🔹 Optimising Processes: by focusing on targeted patient engagement, boosting pharmacists' capacity and confidence, and nurturing the next generation of pharmacists and #PharmacyTechnicians, we can further amplify our impact on healthcare! #CommonAilmentSchemes #PrimaryCare FIP Early Career Pharmaceutical Group FIP-Community Pharmacy Section International Pharmaceutical Federation (FIP)