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BioCentury Extra
As published Friday, August 28, 2015 4:10 PM PST


  • Express Scripts to seek discounts for Repatha, Praluent

    Express Scripts Holding Co. (NASDAQ:ESRX) said its Pharmacy and Therapeutics (P&T) Committee will meet next month to evaluate whether to include PCSK9 inhibitors Repatha evolocumab and Praluent alirocumab in the PBM's formulary. FDA approved Repatha Thursday; the agency approved Praluent last month (see BioCentury Extra, Aug. 27).

    Express Scripts said it would seek discounts based on "natural market competition" that would influence the drugs' costs. Both were approved as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD). Repatha was also approved to treat homozygous familial hypercholesterolemia (HoFH).

    Amgen Inc. (NASDAQ:AMGN) said Thursday it would price Repatha at $542.31 for a single injection, or $14,100 annually, and plans to work with payers to provide "innovative pricing programs" linked to efficacy. Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) priced Praluent at $40 a day, or $14,600 a year.

    The P&T committee will consider drug value assessments produced by the Institute for Clinical and Economic Review (ICER). In July, ICER President Steve Pearson told BioCentury the institute would publish an assessment of Repatha on Sept. 8 (see BioCentury Extra, July 21).

    Express Scripts said it would not exclude either drug from its formulary unless doing so generated significant savings for patients and the covered product was "at least clinically equivalent" to the excluded one. Until the PBM makes a decision, it will make Repatha and Praluent available through a medical exception process.

    CVS Caremark told BioCentury on Friday it will also discuss the new cholesterol treatments at an upcoming P&T committee meeting.

    Other payers may exclude one of the new drugs. Harvard Pilgrim CMO Michael Sherman told BioCentury it would "almost certainly" choose one preferred therapy for its formulary, but declined to give a timeline. Patrick Gleason, director of clinical outcomes assessment at Prime Therapeutics, told BioCentury it anticipates covering only one of the two drugs, and is negotiating with both companies. Gleason said Prime expects to decide in October.

    Sherman and Gleason both said they considered the drugs equally safe and effective, and would choose a preferred therapy based on pricing.

  • Study proposes value-based price for Lilly's necitumumab

    A study published in JAMA Oncology on Thursday proposed a value-based price range of $563-$1,039 per treatment cycle for cancer candidate necitumumab (LY3012211) from Eli Lilly and Co. (NYSE:LLY). Necitumumab is under FDA review in combination with gemcitabine and cisplatin as first-line treatment for advanced squamous non-small cell lung cancer (NSCLC); an FDA decision is expected by year end.

    The study authors said they determined a cost-effective price for necitumumab using data from the Phase III SQUIRE trial, in which three-week cycles of necitumumab plus chemotherapy increased median overall survival (OS) by 1.6 months (HR=0.84) in patients with metastatic squamous NSCLC. The study estimated necitumumab's incremental cost-effectiveness ratio (ICER) to be $100,000-$200,000 per quality-adjusted life year (QALY) gained.

    The paper said under the current payment system for cancer drugs, there is "little incentive for manufacturers and physicians to consider value when pricing and using drugs" and noted that the current cost for new cancer drugs entering the U.S. market "usually exceeds $10,000 per month."

    The JAMA study was NIH-funded and conducted by a research team at Emory University and Georgia Institute of Technology.

    Lilly spokesperson Crystal Livers-Powers told BioCentury a "clinical trial-based analysis will not take into account the range of treatment options available to clinicians and does not reflect real-world choices," noting that the study "excludes commonly used agents that are more expensive than gemcitabine and cistaplin."

    Livers-Powers said it would be premature to discuss necitumumab's price since the human IgG1 mAb against EGFR is not yet approved. Last month, FDA's Oncology Drugs Advisory Committee (ODAC) reviewed Lilly's BLA for necitumumab; the panelists agreed that data supported a positive benefit-risk assessment of the candidate, though some remained concerned about adverse events in SQUIRE and another Phase III trial (see BioCentury Extra, July 9).

  • Ariad soars on takeout rumors

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) declined to comment on rumors that it was approached by Baxalta Inc. (NYSE:BXLT) with an acquisition offer. The biotech surged $2.91 (42%) to $9.89 on Friday and ended the week with a market cap of $1.9 billion.

    "At this point it's speculation and we don't comment on speculation," said Baxalta spokesperson Albert Liao.

    Ariad's pipeline includes Iclusig ponatinib and brigatinib (AP26113).

    Iclusig is a pan-BCR-ABL tyrosine kinase inhibitor (TKI) marketed for forms of acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML). Iclusig's 2Q15 sales were $27.8 million, up from $11.9 million in 2Q14. For the year, Ariad expects product sales of $130-$140 million.

    Brigatinib, a dual inhibitor of anaplastic lymphoma kinase (ALK) and EGFR, is in a pivotal Phase II trial to treat refractory ALK-positive non-small cell lung cancer (NSCLC). The compound has breakthrough therapy designation and Ariad hopes to launch it in 2017.

    Ariad also is planning a Phase III trial of brigatinib versus Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) as front-line therapy.

    Baxalta itself is fending off an unsolicited $30 billion acquisition bid from Shire plc (LSE:SHP; NASDAQ:SHPG) (see BioCentury, Aug. 10).

    Baxalta spun out from Baxter International Inc. (NYSE:BAX) in July.

  • France to reimburse off-label Avastin for AMD

    France's Minister of Social Affairs and Health approved reimbursement for the off-label use of Avastin bevacizumab to treat age-related macular degeneration (AMD).

    In June, the French National Agency for Medicines and Health Products Safety (ANSM) issued a temporary recommendation for use (RTU) for Avastin in AMD. Both the reimbursement and RTU will take effect Sept. 1.

    An RTU is issued for off-label use of a marketed drug and lasts three years (see BioCentury Extra, July 10, 2014).

    Last year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) denounced a similar decision by the Italian Medicines Agency (see BioCentury Extra, June 11, 2014).

    Avastin, a humanized mAb against VEGF, is approved for various cancers but is used off label as a cheaper alternative to Lucentis ranibizumab for ocular indications including AMD. Lucentis, a humanized mAb fragment against VEGF-A, is approved in the EU to treat wet AMD.

    Roche (SIX:ROG; OTCQX:RHHBY) markets Avastin in the EU, while Novartis AG (NYSE:NVS; SIX:NOVN) has EU rights to Lucentis from Roche's Genentech Inc. unit.

    In a statement, Roche said that while it recognizes "budgetary pressures faced by governments, economic considerations must not undermine the EU regulatory system that protects patient interests, particularly when several EU approved medicines are available for intravitreal use in wet AMD."

  • Management tracks

    Specialty pharmaceutical company Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) named James Jones SVP and CMO. Jones was VP, medical, surgery and perioperative care at The Medicines Co. (NASDAQ:MDCO).

    Dr. Reddy's Laboratories Ltd. (NYSE:RDY) said EVP and Head North American Generics Umang Vohra is leaving the company. Alok Sonig, EVP and head India generics, will succeed Vohra.

    Infectious disease play Basilea Pharmaceutica AG (SIX:BSLN) said Chief Technology Officer Ingrid Heinze-Krauss will retire. Guenter Ditzinger, head of pharmaceuticals at Basilea, will succeed Heinze-Krauss, effective Feb. 1, 2016.

    Cancer play CytomX Therapeutics Inc. (South San Francisco, Calif.) hired Rachel Humphrey as CMO. Humphrey was VP and head of immuno-oncology at Eli Lilly and Co. (NYSE:LLY).

    Ophthalmic company Acucela Inc. (Tokyo:4589) named George Lasezkay EVP, legal affairs. Lasezkay was president of consultancy HorizonPharma Group.

  • China finalizes stem cell guidance

    China finalized draft guidance released earlier this year regulating experimental stem cell research, according to state-run newspaper China Daily. The new policy, which is the first of its kind in China, will require studies involving stem cells to be conducted at Class IIIa hospitals with good clinical practices (GCP) certification.

    Chen Yang, a partner at Sidley Austin LLP, told BioCentury CFDA and China's National Health and Family Planning Commission (NHFPC) issued the guidance jointly. Yang said CFDA had previously regulated stem cell products that were part of drug applications, but not other stem cell research.

    Yang said hospitals will be responsible for approving research; however, all stem cell research conducted at the facilities must be registered with CFDA and NHFPC.

    The new rules could encourage sponsors to use the regulatory process, Yang said, because the new pathway is less burdensome than seeking drug approval with CFDA.

    Yang told BioCentury that the final guidance was "almost identical" to the draft version (see BioCentury Extra, April 3).

  • Presidential HIV council pushes HHS for HCV drug access

    The Presidential Advisory Council on HIV/AIDS (PACHA) sent a letter to HHS Secretary Sylvia Burwell recommending steps the federal government could take to increase access to HCV treatments.

    The council criticized current requirements imposed by insurers that make HCV treatments accessible only to certain patients, including those who receive an advanced liver disease diagnosis, abstain from substance use or receive prescriptions only from certain specialty providers.

    The letter said state Medicaid programs should update their access criteria to "eliminate discrimatory policies" and that insurers should require coverage of all HCV drugs and allow for the use of non-preferred drugs with no additional restrictions when it is deemed medically necessary.

    The council also said Medicare, Medicaid and other federal and state programs should disclose the prices they pay for HCV treatments, and that drug companies marketing treatments with an annual cost exceeding $10,000 should disclose R&D and manufacturing costs.

    A 12-week course of Harvoni ledipasiv/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) has a wholesale acquisition cost (WAC) of $94,500 and the WAC for a 12-week course of Gilead's Sovaldi is $84,000. Viekira Pak from AbbVie Inc. (NYSE:ABBV) has a WAC of $83,319 for a 12-week course.

    Neither Burwell's office nor CMS responded to inquiries.

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