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  • Cost and quality: Box: CMS bundles up

    Cancer: Cost and quality CMS bundles up CMS has signaled an interest in a bundled model for cancer reimbursement that would include physician services plus infused and outpatient drugs. The Medicare agency would not…

    Published on 9/15/2014
  • Cost and quality: Box: WellPoint's pathway

    Cancer: Cost and quality WellPoint's pathway WellPoint Inc. is piloting a treatment pathways program that dictates what drugs should be used based on tumor type and stage of disease. Clinicians who follow the …

    Published on 9/15/2014
  • Cancer: Cost and quality

    How cancer reimbursement reform could boost or inhibit drug use

    Payer reforms of cancer care may result in more drug use, depending on how the schemes balance cost-effectiveness and quality outcomes.

    Published on 9/15/2014
  • Betting big on hearts

    How Novartis built clinical case to replace generics in heart failure

    Novartis methodically built a clinical case to show doctors, patients and payers why LCZ696 should replace generics in heart failure.

    Published on 9/8/2014
  • Back to School Issue: Paying the piper

    22nd BioCentury Back to School Issue: Time to try new pricing schemes

    As the drumbeat for cost-based pricing grows louder, the 22nd Back to School essay says industry must experiment with new pricing models in which the cost of a given treatment is based on the patient-defined value of …

    Published on 9/1/2014
  • Box: Best price barrier

    Paying the piper Best price barrier The Medicaid best price rule for outpatient drugs is cited as a barrier to implementing new pricing models in the U.S. Companies that want an outpatient drug to be covered by …

    Published on 9/1/2014
  • Box: Big(ger) in Japan

    Paying the piper Big(ger) in Japan Drug prices in Japan are subject to mandatory reductions after launch, but there is an opportunity for companies to receive a premium, as well as for the price to be increased …

    Published on 9/1/2014
  • Box: Capping Orphans

    Paying the piper Capping Orphans Academics at Duke University have proposed a "grant-and-access" model for ultra-Orphan drugs based on the premise that high R&D costs are limiting investment in these rarest of …

    Published on 9/1/2014
  • Box: Code conundrum

    Paying the piper Code conundrum The U.S. drug coding system presents a challenge for companies that want to try flat pricing schemes. Once a drug is approved in the U.S., CMS establishes a code that connects the …

    Published on 9/1/2014
  • Box: Financing cures

    Paying the piper Financing cures Tanisha Carino of Avalere Health LLC and Scott Gottlieb of the American Enterprise Institute (AEI) both acknowledge that current pricing and reimbursement models are not structured …

    Published on 9/1/2014
  • Box: Pricing Cerdelga

    Paying the piper Pricing Cerdelga Finding U.S. Medicaid pricing regulations too limiting for a bolder experiment just yet, Genzyme Corp. is adopting a version of portfolio pricing lite for two Gaucher's drugs with …

    Published on 9/1/2014
  • Box: Sovaldi nightmares

    Paying the piper Sovaldi nightmares The great Sovaldi debate often overlooks that sofosbuvir is not so much more expensive than the previous standard of care. In interferon-containing regimens for treatment-naïve …

    Published on 9/1/2014
  • Box: Waiting for Kalydeco

    Paying the piper Waiting for Kalydeco Australian health authorities have proposed a pay-for-performance deal for Vertex Pharmaceuticals Inc.'s Kalydeco ivacaftor that would set per-patient reimbursement based on …

    Published on 9/1/2014
  • Figure: Out of room

    Paying the piper Out of room According to IMS Health Holdings Inc., worldwide drug expenditures are climbing out of the patent trough, suggesting that any "room" created by patent expirations was ephemeral. U.S. …

    Published on 9/1/2014
  • Figure: Uphill climb

    Paying the piper Uphill climb In the U.S., average wholesale price (AWP) often goes up even as competitors enter the market. The data below show price increases across five highly competitive categories. Three are …

    Published on 9/1/2014
  • Table: Fast, not cheap

    Paying the piper Fast, not cheap Drug company efforts to improve R&D success rates by developing targeted drugs, plus the combined efforts of industry and regulators to truncate development and approval pathways, …

    Published on 9/1/2014
  • Breathing room

    Almirall COPD assets give AZ time for respiratory pipeline to mature

    AstraZeneca's acquisition of Almirall's respiratory assets should buy time until other compounds in the pharma's pipeline mature.

    Published on 8/18/2014
  • Figure: Respiratory sales

    Breathing room Respiratory sales AstraZeneca plc (LSE:AZN; NYSE:AZN) expects to almost double respiratory revenues to about $8 billion by 2023. However, the company is still well behind GlaxoSmithKline plc (LSE:GSK;…

    Published on 8/18/2014
  • Table: AZ-Almirall respiratory pipeline

    Breathing room AZ-Almirall respiratory pipeline Although its deal with Almirall S.A. (Madrid:ALM) doesn't give AstraZeneca plc (LSE:AZN; NYSE:AZN) any clinical assets with mechanisms of action it doesn't already …

    Published on 8/18/2014
  • Table: Deeply Novel

    Breathing room Deeply novel AstraZeneca plc (LSE:AZN; NYSE:AZN) appears to have more clinical compounds targeting a wider range of novel targets/mechanisms of action for asthma and chronic obstructive pulmonary …

    Published on 8/18/2014
  • LDT blurred Lines

    FDA has set the playing field for regulatory, legislative endgame on LDTs

    FDA's planned draft guidance on lab developed test sets up the playing field for the regulatory and legislative endgame on LDTs.

    Published on 8/11/2014
  • Table: FDA-approved companion diagnostics

    LDT blurred Lines FDA-approved companion diagnostics FDA has approved 19 companion diagnostics for 13 drugs. Stakeholders contacted by BioCentury expressed concern that the agency's resources could be overwhelmed …

    Published on 8/11/2014
  • FDA's quality crusade

    FDA plans sea change in regulation of drug manufacturing quality, innovation

    FDA says its Office of Pharmaceutical Quality is a 'game changer' that will spur manufacturers to innovate and compete on quality.

    Published on 8/4/2014
  • Figure: Beyond batch

    FDA's Quality Crusade Beyond batch: Continuous manufacturing integrates all steps of production - from start to finish - into a single process in one location. Source: Novartis AG

    Published on 8/4/2014
  • Partnering Afrezza

    What challenges await potential partner for MannKind's Afrezza inhaled insulin

    Its inhaled insulin approved, MannKind now must persuade any marketing partner to invest in answering a new host of questions.

    Published on 7/28/2014

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