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Policy & Regulation

Scrip Asks...What Does 2019 Hold For Biopharma? Part 3: Pricing, Reimbursement And Market Access

How much therapies should cost and how they should be reimbursed are questions that are expected to dominate in 2019, according to industry experts and participants surveyed by Scrip on their expectations for the coming year. This is the focus for the final installment of our three-part Scrip Asks series.

Pricing Debate Pricing Strategies Reimbursement

Roche Calls For Harmonized Regulation As Subcutaneous Herceptin Is Denied Trial Waiver In India

Roche’s subcutaneous (SC) Herceptin (trastuzumab) has been declined a trial waiver in India, at least for now, stretching potential launch timelines for the product significantly. The company emphasizes that a harmonized regulatory approach could best serve patient interests for therapies like Herceptin that come with a ‘long history of proven efficacy’.

Policy & Regulation Clinical Trials Biosimilars
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Policy

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Latest From Policy

US Drug Pricing: What A Difference A Year Makes

Drug makers were optimistic going into 2018 about the political climate and drug pricing environment, but the outlook is more tenuous heading into 2019. Now is the time when industry raises prices on mature, marketed drugs and it's unclear how those hikes may be tempered or what the backlash might be.

Pricing Debate Pricing Strategies

Pharma: Be Prepared For Tougher Price Negotiations For IO Combos And Expansions In Europe

Payers are increasingly likely to implement new strategies to manage price negotiations for immuno-oncology combinations, as competition  heats up among the drug class. Mechanisms allowing for the negotiation of different prices for combination therapies do not exist at present, but payers insist that new tools must emerge.

ImmunoOncology Health Technology Assessment

Lilly CEO Made New IFPMA President On Health Budget Mandate

David Ricks will lead IFPMA into 2020 with an eye on how to meet the healthcare needs of the world’s aging population, and stepping up the power of private-public partnerships.

International Leadership

Medical Research Council Hopes To Build On UK / China AMR R&D Collaborations

Financial grants are bringing UK and Chinese researchers together in bilateral collaborations to fight the growing global threat from antimicrobial resistance.

Infectious Diseases Emerging Markets

No, It's Not Just Out-Of-Pocket Costs That Are A Problem, John Arnold Tells Pharma

The billionaire philanthropist and industry agitator took the stage at the Forbes Healthcare Summit to discuss why his foundation is focused on fixing drug pricing and supporting organizations like ICER and Patients for Affordable Drugs.

Pricing Strategies Policy

Industry Wants US Rebate Reform, But What Does That Mean?

Drug makers are bracing for a potential new policy change around rebating that could change the way they price drugs and negotiate market access. But some in the industry are advocating for a less disruptive new discounting system over the elimination of rebates all together.

Pricing Debate Reimbursement
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Regulation

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In A Record Year For US FDA Approvals, Pfizer Came Out On Top

FDA’s approval teams cleared a total of 65 new molecular entities and novel biologics in 2018, blowing past previous records. Scrip looks at how that breaks down for industry leaders. 
Approvals Drug Review

Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018

New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.

Approvals Europe

Luxturna Approved In EU: Novartis Outlines Lessons For Gene Therapy Strategies

The European Commission has officially approved Luxturna, Novartis/Spark Therapeutics’ transformative gene therapy. The Swiss firm tells Scrip how the lessons it expects to learn from launching its first gene therapy will inform its future strategy in this new field.

Innovation Approvals

Vertex Secures Hat Trick Of Europe CF Approvals With Nod For Symkevi

Now that the EMA has followed its US counterpart in granting approval for its cystic fibrosis drug Symkevi, Vertex will once again have to navigate Europe's various reimbursement systems, with observers keeping a close eye on how talks with NICE go.

Approvals Reimbursement

Genentech, Amgen Face Big Impact From Part B International Pricing Index

Medicare spending on Genentech’s Rituxan and Lucentis, and Amgen’s Neulasta and Prolia/Xgeva, would have been $3.8bn less in 2016 using the proposed international pricing index model, CMS estimates.

Pricing Debate Medicare

Esperion Expects Preferred Formulary Placement For Oral Cholesterol Drug Bempedoic Acid

Final Phase III study for pivotal package of cholesterol drug bempedoic acid shows LDL-lowering efficacy and a clean safety profile, paving the way for filings in the first half of 2019.

Cardiovascular Research & Development
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