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Wednesday, October 10, 2018

Novartis, Pfizer, AZ and more hand China 50%-plus cancer drug discounts


China is quickly approving many of the newest cancer drugs but it also is demanding big discounts if drugmakers want them on its national insurance coverage list. In fact, in the latest round of negotiations, drugmakers offered up discounts averaging 56.7% for medications that included blockbusters from Novartis, Pfizer and AstraZeneca.
All together, 17 cancer drugs (full list below) reached deals with the Chinese government for inclusion on the country’s National Reimbursement Drug List. Of them, 10 are relatively new drugs that just reached China this year or in 2017.
Novartis appears to be the biggest winner, with four drugs listed, followed by Pfizer’s three. But among the 18 drugs originally chosen for final talks, Novartis’ myelofibrosis therapy Jakavi was the only one left without a deal.
AstraZeneca offered the largest discount, 71% for its third-generation EGFR-TKI Tagrisso, according to China Health Insurance, a magazine supervised by China’s Ministry of Human Resources and Social Security. The drug previously cost about 1,760 Chinese yuan ($254) per 80mg pill and will now cost CNY 510.
In addition, Pfizer also cut the prices for renal cell carcinoma drug Inlyta and ALK-positive lung cancer med Xalkori by more than 70%.
Lung cancer is one of the most sought-after therapeutic areas. Boehringer Ingelheim’s Giotrif and Novartis’ Zykadia, which fight head-to-head against Tagrisso and Xalkori, respectively, are now also on the roster. Focus V (anlotinib), developed by local firm Chiatai Tianqing (CTTQ) for third-line non-small cell lung cancer, is the fifth one in this category.

These drugs’ new prices will be subject to re-evaluation after Nov. 30, 2020, and if any generics are approved before that or if the actual market price comes down significantly, authorities will consider adjustment, said the newly formed State Medical Insurance Administration, which negotiated the latest price cuts with companies.
While China has been speeding its drug review, it has also been cracking down on cancer drug prices amid a growing domestic outcry calling for affordability—and as its insurance fund runs tight. It recently removed import tariffs on cancer drugs and cut their import value-added tax to 3%, and then immediately pressured drugmakers to adjust their prices accordingly.
Because the country operates a national medical insurance scheme, getting onto the list means much wider patient reach for biopharma companies. But in the meantime, they’ll need to carefully examine the market to understand the level of discount they can afford in exchange for volume growth.

The government and companies must walk a delicate balance, and China’s state-run China Central Television (CCTV) gave a rare glimpse into the process. It includes document submission from the companies, expert evaluation based on millions of data and pharmacoeconomics models, and culminates in a 30-minute-per-drug face-to-face negotiation.
Erbitux, marketed in China by Merck KGaA, failed the previous 2017 round. This time, according to CCTV, a company’s Chinese representative sought instructions from headquarters several times during the closed-door bargaining, as the government’s ask went below what he had been authorized. In what the executive called “the lowest price in the world,” the drug got its deal by taking a 69% discount, to CNY 1,295 per vial.

Full list of 17 drugs to be covered by China’s national insurance

CompanyDrugInsurance Price (CNY)
NovartisSandostatin7,911 (30mg); 5,800 (20mg)
Tasigna94.7 (200mg); 76 (150mg)
Zykadia198 (150mg)
Votrient272 (400mg); 150 (200mg)
PfizerXalkori260 (250mg); 219.2 (200mg)
Inlyta207 (5mg); 60.4 (1mg)
Sutent448 (50mg); 359.4 (37.5mg); 263.5 (25mg); 155 (12.5mg)
AstraZenecaTagrisso510 (80mg); 300 (40mg)
Boehringer IngelheimGiotrif200 (40mg); 160.5 (30mg)
BayerStivarga196 (40mg)
Celgene/BeiGeneVidaza1,055 (100mg)
JanssenImbruvica189 (140mg)
TakedaNinlaro4,933 (4mg); 3,957.9 (3mg); 3,229.4 (2.3mg)
Merck KGaAErbitux1,295 (100mg/20ml)
RocheZelboraf112 (240mg)
Chiatai TianqingFocus V487 (12mg); 423.6 (10mg); 357 (8mg)
Hengrui PharmaPegaspargase2,980 (5ml:3750IU); 1,477.7(2ml:1500IU)

CVS, Aetna win U.S. approval for $69 billion merger


Pharmacy chain CVS Health Corp (CVS.N) won U.S. antitrust approval for its $69 billion acquisition of health insurer Aetna Inc (AET.N), the Justice Department said on Wednesday, paving the way for a combination the companies say can help cut soaring U.S. healthcare costs.
It is the second large recent healthcare deal to win a thumbs up from the U.S. Justice Department. The agency gave the green light to health insurer Cigna Corp’s (CI.N) $52 billion acquisition of the nation’s largest pharmacy benefit manager (PBM), Express Scripts Holding Co (ESRX.O), on Sept. 17.

Shares of CVS and Aetna each rose about 1 percent on Wednesday, a day when the broader market was sharply lower, with CVS trading at $80.25 and Aetna at $206.00.
The deal was approved on condition that the company’s sell Aetna’s Medicare Part D prescription drug business, the Justice department said.
Aetna last month said it would sell all of its standalone prescription drug plans for the government Medicare program for Americans aged 65 and older and the disabled to WellCare Health Plans Inc (WCG.N), paving the way for the deal’s approval.
Without the divestiture the two companies would have owned more than a 30 percent share of the Medicare Part D drug plans, creating concern about the amount of control the new CVS would have had over the Medicare prescription drug market.
Together the two have 6.8 million members in Medicare Part D drug plans, the Justice Department said.
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“The divestitures required here allow for the creation of an integrated pharmacy and health benefits company that has the potential to generate benefits by improving the quality and lowering the costs of the healthcare services that American consumers can obtain,” Makan Delrahim, head of the department’s Antitrust Division, said in a statement.
The companies have said they believe together they can improve customer health by offering more low-priced medical services in CVS’s nationwide network of pharmacies, including providing chronic disease screenings and preventative care, such as blood sugar monitoring and vaccines.
CVS also has a large PBM business.

Walmart Canada exploring possible sale of cannabis-based products


Walmart Inc’s Canadian unit said on Tuesday it is exploring the possibility of selling cannabis-based products, but has no immediate plans to get into the business.

The company’s shares rose nearly 3 percent to $97.48 in afternoon trading.
Walmart is the first major retailer to show an interest in being a part of Canada’s burgeoning marijuana industry, as other big U.S. companies, mainly in the alcohol and beverage industries, begin to consider entering the market for cannabis-infused products.
Last month Coca-Cola Co said it was closely watching the marijuana drinks market for a possible entry, while Corona beer maker Constellation Brands has invested more than $4 billion in cannabis producer Canopy Growth.
“Walmart Canada has done some preliminary fact-finding on this issue, but we do not have plans to carry CBD products at this time,” Walmart spokeswoman Diane Medeiros told Reuters.
Cannabidiol or CBD is the non-psychoactive chemical found in marijuana and does not cause intoxication.
The news comes as Canada is on the verge of becoming the first major economy to legalize recreational marijuana on Oct. 17, and shares in cannabis producers have rallied in anticipation.
New Cannabis Ventures’ global cannabis stock index has risen about 87 percent over the past year.
The legal cannabis market in Canada will target an estimated 32 million adults by 2025 and drive about C$10.4 billion in retail market sales, Roth Capital Partners analyst Scott Fortune wrote in a client note.
The move by Canada could spur other countries to legalize recreational marijuana use.
“An investment blueprint has been established in Canada that we believe will play out internationally very similarly,” Fortune said.
Several U.S. states have also legalized use of recreational or medical marijuana, but it remains illegal under federal law.

Reversal for AcelRx Pharma, gains on potential panel thumbs up for Dsuvia


AcelRx Pharmaceuticals (ACRX +26.4%) is up on a 10x surge in volume on expectations of a positive vote from an FDA advisory committee this Friday related to pain med DSUVIA (sufentanil sublingual tablet). Shares were down over 50% at one time premarket before recovering.
The company appears to have sufficiently addressed the review team’s concerns over the safety of the 30 mcg tablets at maximum dosing and the risk of misplaced tablets, two areas cited in the CRL the company received in response to its original filing.
To address the dosing issue, ACRX lowered the maximum daily dose to 12 tablets from 24 and provided new pooled safety data. To address the potential for misplacing tablets, it modified the directions for use and conducted another human factors study (page 6 in the FDA briefing doc).

Aetna up 1% after report on pending DOJ approval for CVS deal


Shares of Aetna (AET) are up roughly 1% in pre-market trading after Bloomberg said a source familiar with the matter indicated that the Department of Justice antitrust division will sign off on a settlement clearing the way for CVS Health’s (CVS) deal to buy the insurer as soon as today. Following Bloomberg’s report on the expected antitrust clearance, CVS Health shares are also up 0.6%.
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Cerner win at Northwell Health is significant, says Piper Jaffray


Piper Jaffray analyst Sean Wieland says he learned at Cerner’s (CERN) user group conference that Northwell Health, the largest health system in New York, will launch the company’s Soarian revenue cycle product across its 23 inpatient facilities, beginning with Huntington Hospital in May. This win is significant for Cerner and proves the staying power of Soarian, Wieland tells investors in a research note. Further, Northwell uses Allscripts (MDRX) for its inpatient electronic health records, and losing this opportunity to Cerner “goes against the grain of Allscripts’s strategy to bring all of their customers into one unified Allscripts platform,” Wieland adds. He believes integration with Salesforce (CRM) provides Cerner with a strong competitive advantage and reiterates an Overweight rating on the shares with a $71 price target.

Genentech: OCREVUS Early Initiation of Treatment Cuts Disability Progression


  • People with relapsing MS (RMS) treated sooner with OCREVUS had earlier reduction in disease activity and less disability progression vs. those who switched from interferon beta-1α
  • People with primary progressive MS (PPMS) treated with OCREVUS earlier had less disability and upper limb progression than those who switched from placebo
  • Longer-term safety data are consistent with OCREVUS’ favorable benefit-risk profile for both RMS and PPMS
  • OCREVUS approved in 68 countries, with over 70,000 patients treated globally
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new OCREVUS® (ocrelizumab) data will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 10-12 in Berlin, Germany. Five-year data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO show OCREVUS efficacy is maintained on key measures of disease activity and that people treated earlier with OCREVUS had superior disability progression outcomes compared with RMS patients who switched from interferon beta-1α or PPMS patients who switched from placebo.