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Japanese have easy access to new medicines, whose prices are decided by the government and subsidized by the country’s public health insurance system...But that may change. Japan, confronted with the ballooning cost of caring for an aging population, is introducing a cost-effectiveness test for drugs as a means of capping prices...There are no plans to deny care for patients of any age... Japan should carefully consider an impact on the industry when introducing such analysis to reduce drug prices...If Japan is going to cut prices so much, I think Japan will really run a risk of losing its current position...while drugmakers threaten to pull back from Japan, the government is prepared to call the industry’s bluff, saying Japan is too lucrative a market for companies to ignore... Unlike the United States, where insurers may deny claims, or the UK, where patients can be denied costly drugs, Japan is seen as a relatively predictable market because of its social insurance system...

Last year, the FDA once again set a new record for new drug approvals and far surpassed its 10-year average...Since being sworn in as FDA commissioner in 2017, Scott Gottlieb has made drug approvals a top priority for the agency. In 2018, the FDA made moves to streamline its entire drug approvals process — from early development to final application submissions...the FDA plans to continue removing barriers to generic drug competition by helping ensure access to brand-name biologic drug samples and cutting back on the number of review cycles companies have to go through to get generics approved...

CDER Drug Approvals

59 = New molecular entities approved...jump from the 46 approvals in 2017

64 = percentage of NMEs that were small molecules...20 percent...were antibodies.

34 = NMEs orphan drugs...that target rare diseases...

19 = approvals that were first-in-its-class therapies...

16 = Cancer drugs approved...

3 = New preventative migraine treatments...

73 = percentage of NME approvals that CDER expedited

971 = number of generics that were approved or tentatively approved...

Sanofi SA and Regeneron Pharmaceuticals Inc said...that they will slash the U.S. list price of their potent but expensive cholesterol fighter Praluent by 60 percent, as the drugmakers follow a similar move by rival Amgen Inc in hopes of increasing use of the drug...The new list price for Praluent will be $5,850 a year, matching the price Amgen set when it lowered the list of its competing drug, Repatha...Sanofi and Regeneron said they expect the lower-priced Praluent to be available for pharmacies to order in early March. They said the new price should improve patient access and result in lower out-of-pocket costs for U.S. consumers...

Canadian pharmaceutical industry lobby groups, in an effort to head off a planned crackdown on prescription drug prices, offered to give up C$8.6 billion ($6.6 billion) in revenue over 10 years, freeze prices or reduce the cost of treating rare diseases...Those industry offers did not impress federal officials, coming last year as Canada prepared to expand the powers of a little-known federal watchdog called the Patented Medicine Prices Review Board to reduce the cost of prescription drugs...The government proposals would change the countries Canada compares its prices to, dropping the United States where they are highest, and set a formula to assess cost-effectiveness of medicines...the new rules were scheduled to come into effect last month but have been delayed as the government reviews feedback, which has some wondering if they will ever be implemented...Unlike other countries with universal healthcare, Canada’s government-funded healthcare system does not cover prescription drugs. Most Canadians rely on an expensive patchwork of public and private insurance plans for that. Among industrialized nations, only the United States and Switzerland spend more on prescriptions per capita...

...In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients...We’ve been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development...We’re working to reduce barriers to generic development and to lower the cost of generic entry so that more of the generic medicines that the FDA approves are launched and reach patients...

- issue draft guidance with recommendations on establishing active ingredient sameness.

- development of new analytical tools and in vitro tests to provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs.

- laying out new, efficient guidelines for the use of a novel pathway that provides incentives for developing generic versions of drugs that currently face little or no competition - Competitive Generic Therapies

Critics often target physicians who receive money from pharma, but the exact influence those payments have on prescribing is up for debate. In oncology, at least, it’s not one-off payouts but consistent compensation that's most likely to sway prescribing behavior...the study showed that physicians who received payments over three consecutive years and tied to a specific drug boosted their prescriptions of that product. That pattern applied to oral drugs that treat lung cancer, kidney cancer and chronic myeloid leukemia...Among physicians who received payments from drug companies during only one year, no pattern emerged...

Johnson & Johnson will put list prices in its drug TV ads. It’s the first pharma to announce that plan, self-regulating ahead of a proposed Trump administration rule that would force all pharma companies to add list prices to TV commercials...J&J pharma arm Janssen will begin with its most prescribed drug, the oral anticoagulant Xarelto, adding both list price and potential out-of-pocket costs to its TV spots later this quarter. It will add prices to its other medicines, too, J&J said in a statement. It’s planning to weigh patient and consumer feedback on the Xarelto changes as it rolls out the follow-ups...J&J’s move combines the Health & Human Services list price mandate with the pricing principle plan that members of the trade association PhRMA agreed upon earlier this year. That plan would offer consumers a broader explanation of costs by linking ads to online or telephone explanations of expected out-of-pocket expenses and insurance coverage.

Under a proposal...Medicare would cover CAR-T cell therapies through a Centers for Medicare and Medicaid Services pathway known as Coverage with Evidence Development...The proposal holds a mix of provisions, including that patients must be monitored for at least two years post-treatment. Hospitals administering CAR-T therapy, whether through inpatient or outpatient care, must participate in a CMS-approved registry that collects data on patient outcomes and characteristics and then compares that data to what's been seen in pivotal clinical trials of the therapy or standard of care treatment...Hospitals and clinicians would track certain clinical data elements at baseline, at treatment, and then at three-month, six-month, one-year and two-year follow ups following administration...

A week after the Trump administration proposed ending drug rebates in federal health programs—and then urged Congress to extend that plan to commercial insurance—supply chain players are hitting back. The pharmacy benefit manager industry has even launched an ad campaign...But drugmakers are a different story. Eli Lilly CEO David Ricks said...that the proposal could “be a win for patients, lowering their out-of-pocket costs at the pharmacy counter," and inspire pharma to do more to demonstrate the value of their products...nixing rebates would “remove an artificial barrier to competition, creating space for innovation that addresses unmet needs for patients," Ricks said...

Many more Americans may be getting opioids for their pets, and veterinarians appear to be prescribing increasingly potent versions of these drugs to animals...The researchers examined data on opioid tablets and patches dispensed or prescribed by 134 veterinarians at an academic small-animal hospital in Philadelphia from 2007 to 2017. Over the decade, the amount of opioids used for creatures like rabbits, birds and reptiles surged 41 percent even though visits to the hospital increased by only 13 percent...