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Winning Payer Support for Companion Diagnostics Biomakers
How can you positively influence payer attitudes to biomarkers and companion diagnostics CDx?
Biomarkers and CDx are critical to realising the personalised medicines agenda. They support clinician decision making and are cost efficient for payers. But payers identify challenges around evidence of clinical utility, inconsistent practice between and within countries, and question who, ultimately, should pay the biomarker/CDx bill. What can pharma, biomarker and CDx developers learn from these critical insights?
In Biomarkers and Companion Diagnostics: Payer Insights, 10 US and EU5 payers with expertise in product assessment, formulary management and healthcare strategy reveal the touchpoints that impact payer decision making and the ways industry can both meet their needs and achieve successful commercial outcomes.
Key Questions Answered by this report:
Each industry expert has been carefully selected for their practical experience and detailed current knowledge of payer pressures and the payer/pharma relationship.To ensure candid responses, the identities of all respondents have been kept anonymous./P>
This individual is a key influencer on a pricing and reimbursement committee and he has particular awareness of current and evolving trends in biomarkers and companion diagnostics. His department comprises research units in clinical pharmacology and pharmacoepidemiology and he is directly responsible for purchasing relevant highimpact medicines that have associated biomarkers/CDx.
The Head of Pharmaceutical Management at a company that represents 40 sick funds in the German healthcare system covering eight million lives. This individual is involved in price negotiations at the GKV in the AMNOG process, and is part of the negotiation team for every new drug in Germany, including those with companion diagnostics.
This individual is a chief hospital pharmacist who is involved in the purchasing of drugs and devices for the hospital and takes part in local and regional formulary discussions. At regional level, the payer has roles in the laboratory component of Pharmacoeconomics, the National and RegionalHospital Committee for the Formulary, the Ethics Committee, the Committee for Good Use of Blood, and the Hospital Infection Committee.
This individual is a payer and pharmaceutical economic expert in Spain; a member of the Spanish Agency for Medicines and Health Products AEMPS and committee member of a Clinic Hospital Pharmacy; an Economics University Professor and Consultant for the Ministry of Health, InterMinisterial Commission for Pharmaceutical Prices CIPM Activity.
This individual works as a Commissioning Lead Pharmacist. She is responsible for medicines optimisation and commissioning high cost drugs. Her work includes pathway development, gain share and service improvement involving both primary and secondary care clinical engagement. She is also responsible for working with the pharmaceutical industry on new products and joint working initiatives. She is a member of the Medicines Evaluation Committee and District Prescribing Committee. Previously, she worked in the pharmaceutical industry.
US Payer 1
As a Medical Director on the Clinical Policy Team who sits on the Technology Assessment Committee that uses companion diagnostics for coverage and reimbursement, this individual is a licensed pharmacist in New Jersey. With more than 30 years of experience providing pharmacy services in a retail and clinical setting, he has a track record of establishing positive relationships with customers, pharmaceutical manufacturers, medical professionals, healthcare organisations and insurance providers.
US Payer 2
This individual's career spans 35 years with experience in staff, group and IPA model health plans as well as Managed Medicaid and Medicare Part D programmes. Currently the Manager of Specialty and Pharmacy Contracts at a fullservice health benefits company covering over 1.3 million lives in the New England market. In this role, he negotiates pharmaceutical rebate contracts, specialty pharmacy contracts and participates in formulary management, benefit design, trend analysis, utilisation review programmes, pipeline monitoring, medical drug management and financial modelling for the pharmacy programme.
US Payer 3
This individual oversees all clinical and purchasing services for CPS, including clinical programme development, corporate purchasing process, clinical education, quality disease state management and clinical contract evaluation. His extensive background includes serving as Clinical Coordinator at several large and small hospitals, Director of Disease State Management for a large physician group as well as Pharmacy Director and Pharmacy Buyer.
US Payer 4
This individual is Chief Pharmacy Officer and Business Director for an innovative prescription drug benefit initiative. The Rx benefit serves over 600,000 selfinsured enrolees, primarily in the public sector, and provides consultative guidance and support to its clients in the areas of benefit design and analysis, clinical programme design and selection, formulary development and trend management.
US Payer 5
This pharmacy expert is responsible for pharmacy contracting and related supply chain activities as part of a pharmacy and therapeutics committee. He has more than 38 years of experience in a variety of roles, including Director of Pharmacy Operations, Manager of Pharmacy Purchasing and Distribution, and Area Chief Pharmacist. He has extensive expertise in pharmacy utilisation strategies and drug benefit design. With regard to diagnostic testing and biomarkers, he is involved in the approval process and in determining the value of reimbursement.
3 Key Quotes
We have around 20 companion diagnostics in Germany. For [specific] drugs, the testing is reimbursed and for all other tests there is no reimbursement There is no negotiation about the cost of the test; if it costs 1,000 [or] 2,000, there is no negotiation and it is reimbursed over the EBM system. German Payer
If you just have a NICE guideline where it [the biomarker] is just briefly mentioned, then you get a huge amount of variation from different hospital trusts as to how they implement that, whereas if it is something that is targeting treatment, then more national support with local buyin is where we would want to be. So, for example, we have got an oncology biomarker in which my hospital, as a research centre, is very interested so it's selffunding for patients; whereas there is another hospital that is also within my area, where even though the NICE guideline says it is costeffective and you should use it, it is not used at all. [This is] because there is no additional payment for it, so it would have to come from the existing hospital tariff, and there is no incentive for them to use it."UK Payer
There's a general rule: does the diagnostic have a direct impact on the care? There are some diagnostics that are curious. Let's say we have a diagnostic that tests for ALK+ cancer patients; it's 60% predictive [and] 40% of the time it's inconclusive. We wouldn't want to pay for that test because if the patient's going to get the drug whether the test is positive, negative or inconclusive, then why bother paying for the test? So, with a positive test you get the drug, and a negative test you don't, then obviously the positive tests are the ones you want to cover. US Payer 2
I think risk sharing is a great concept. Nothing's absolute, so I would never expect it to be 100 percent, but I would say 50:50 or 70:30. Something where everybody has a stake in it.US payer 3
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