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Value-based care represents a new set of strategies that aim to reduce wasteful healthcare spending. It includes replacing branded drugs with cheaper generics, using financial incentives to encourage the use of certain drugs on a payer's formulary and insurers electing to cover certain prescription drugs at a lower co-pay…value-based approaches to addressing rising drugs are a possible lever for reducing wasteful healthcare spending—but defining value for payers, drugmakers and patients remains a serious obstacle to adoption…“We don't have a common definition of ‘value-based.' Every other industry has figured out how to do this in a free-market system…Drug pricing has hit an inflection point...There has been new scrutiny from lawmakers and presidential candidates over how drugmakers price their medicines…Some pharma companies have started to publicly discuss new strategies such as risk-sharing or value-based pricing that would support giving high prices for innovative new therapies…pharma needs to show leadership in moderating the prices of established products.

Junior doctors are due to start a series of strikes starting on December 1st, with two days of full walk-out on December 8 and December 15th… December could see the first ever full walk-outs by doctors in the history of the NHS…Following a ballot by the British Medical Association, junior doctors will provide "emergency care only" action for 24 hours on December 1, followed by a full walk out from 8am to 5pm on December 8 and December 16…Hospitals will be forced to cancel most planned operations and outpatients appointments, and to roster as many senior doctors as possible to cover emergency care. On Wednesday, the Health Secretary agreed to send health officials into talks via Acas, which the BMA welcomed - raising the prospect that the strikes could be called off…the union said it would not call off three days of strikes - due to start on December 1 - unless the Government went further, removing threats to impose a new contract on junior doctors if agreement cannot be reached.

In New Jersey, a bill (A2477) authorizing pharmacists filling a prescription for a biological medication to select an interchangeable biological product, was signed into law…A substitution cannot be made if the prescriber indicates that there shall be no substitution. The law requires the New Jersey State Board of Pharmacy to maintain a link on its website to FDA’s current list of interchangeable biological products. Further, the law requires a pharmacist or designee to notify the prescriber of the biological product dispensed, including the name of the product and the manufacturer, within five days…The pharmacist is also required to record on the prescription label, and record of dispensing, the product name of the interchangeable biological product, followed by the words “Substituted for” and the name of the biological medication for which the prescription was written, and the manufacturer of the interchangeable biological product.

Medicines Patent Pool…announced its first licence for a hepatitis C medicine, signing an agreement with Bristol-Myers Squibb for daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the HCV virus. The royalty-free licence will enable generic manufacture of daclatasvir for sale in 112 low- and middle-income countries (LMICs)...Nearly two-thirds of all patients living with hepatitis C in the LMICs reside in the territory covered by this agreement…Hepatitis C is a major public health threat affecting up to 150 million people globally, with the vast majority living in low- and middle-income countries. Earlier this year the World Health Organization added several new hepatitis C treatments, including daclatasvir, to its Essential Medicines List, underscoring the urgent need to promote equitable access to innovative medicines.

New data show the staggering reach of the prescription drug epidemic...Doctors wrote 259 million opioid prescriptions for Americans in 2012, enough to medicate every adult in the country. Drug overdoses are eclipsing car crashes as a leading cause of accidental death for American adults…A poll out today from the Kaiser Family Foundation adds a troubling new number to the accounting: 27 percent of Americans report that they either have been addicted to prescription painkillers or have a family member or close friend who has…That's roughly 66 million U.S. adults for whom the opioid crisis has become intensely personal…Prescription drug addiction and a related heroin epidemic have proven a stubborn public health crisis since painkiller abuse began rising more than a decade ago…Kaiser's poll found strong majorities in support of policy solutions, including drug treatment, tighter scrutiny of prescribers, and "good samaritan" laws that protect drug users from being charged if they call for help when addicts overdose.

…stakeholders gathered at HHS' Pharmaceutical Forum…CMS Acting Administrator Andy Slavitt said millions of Medicare and Medicaid beneficiaries, as well as individuals enrolled in the Children's Health Insurance Program or health plans through the Affordable Care Act's insurance exchanges, "rely on prescription medications to manage chronic illnesses and treat acute conditions." However, surveys have shown "that as costs go up, so does everyone's anxiety about their continued access to their prescription medicine," he said…"As we encourage the development of new generations of highly targeted, personalized therapies, we need strategies for ensuring access to these innovations."

Laying Out the Problem
What's Been Proposed?
   Negotiating Drug Prices, Increasing Rebates in Medicare
   Cost-Sharing Caps
   Expediting Drug Approval
   Reforming Specialty Drug Reimbursements
No Consensus on Which Plan To Choose

Centers for Medicare and Medicaid Services have finalized a rule regarding the Medicare reimbursement methodology for biosimilar products. Biosimilars…approved …as being “highly similar” to a specific biologic medication…patients may respond differently to the reference product and the biosimilars...there is now a debate as to whether or not biosimilars should be paid with a single billing code based on the ASP (Average Sales Price) of all biosimilars for a single reference product, as has been finalized by CMS, or the ASP for each individual biosimilar, separately from any other biosimilar of the same reference product…Economic arguments and patient safety concerns may support the latter, though the statutory text regarding this matter is somewhat ambiguous…the decision over how biosimilars…should be reimbursed…should be determined by economic principles based on the value of the medication to patients and without putting patient safety and access to such products at risk. If the statutory text does not clearly provide for the favorable regulatory outcome of these factors, it should be amended.

U.K. will give taxes raised from the sale of tampons and sanitary towels to women’s charities, Chancellor of the Exchequer George Osborne announced…Money raised from the 5 percent value-added tax on sanitary products will go to cancer charities The Eve Appeal and The Haven and to SafeLives and Women’s Aid, which are dedicated to ending domestic abuse,...Britain will negotiate with the European Union to scrap the tax…“We already charge the lowest 5 percent rate allowable under European law and we’re committed to getting the EU rules changed,” Osborne said in his Autumn Statement to Parliament in London Wednesday. “Until that happens, I’m going to use the 15 million pounds a year raised from the tampon tax to fund women’s health and support charities.”…More than 270,000 people have signed a petition calling for the tax to be removed. It is imposed because the products are defined as “non-essential luxury items” and, while it was reduced to 5 percent...EU law currently prohibits a zero rating.

It’s far too early to declare with certainty the impact of the ICD-10 transition on healthcare revenue cycles and productivity…Initial data shows the apocalyptic warnings about ICD-10 immediately leading to claims rejection chaos were misplaced. The Centers for Medicare and Medicaid Services late last month said invalid ICD-10 codes comprised only 0.09% of error-based denials from October 1 through October 27…While CMS said it was “pleased to report that claims are processing normally,” it’s worth keeping in mind that the government agency has taken several temporary steps to smooth the transition to ICD-10 which may be masking problems that could manifest themselves down the road, including a claims denial amnesty for 12 months and advance payments to physicians in the event of processing problems related to ICD-10… Providers that considered themselves unprepared for ICD-10 as October 1 approached shouldn’t assume their currently low claims rejection rates mean their self-assessment was overly pessimistic. If they felt they were unprepared, they probably were. And if they were unprepared for ICD-10 on October 1, they probably still are…To avoid an unpleasant reality check down the road, providers with any doubts about their ICD-10 readiness should continue training and testing.

With rising drug prices such a hot topic here, drug makers and health insurers are both coming under heavy fire…So much fire that they’re considering a radical response: working together…After years of relentlessly attacking one another, leaders of the pharmaceutical industry and the health insurance lobby are considering — warily — cooperating to shape any federal legislation that emerges from the public outrage at the high cost of medications…The two powerful lobbies remain fundamentally at odds in their agendas: In the most basic terms, drug makers want to make as much money as they can for their medicines, and insurance companies want to pay as little as possible…both are under a lot of pressure from Congress and the Obama administration to figure out a unified response to high drug prices...Here’s a guide to the key players — and their agendas.

• Health insurers…want to work with drug makers, but they expect major concessions.
• Drug makers…“Medicines that truly represent value should merit a larger price.”
• So what now?

Old habits die hard, though. Even as leaders in both lobbies talk about a kumbaya moment, shots are still being fired. Earlier this month, a drug industry-backed group put out a report accusing health insurers of “hiding profits to justify raising prices.”...Just a few hours later, Tavenner’s group (health insurers)released a report of its own, asserting that drug companies “continue to demand a blank check, driving up costs across the board for everyone.”