- Promise Of High Prices Now Driving Biopharma R&D Investments (forbes.com)
Once again, the biopharmaceutical industry had another banner year in 2015...in comparing the approvals of 1996 to 2015, a lot has changed over the years...the vast majority of drugs approved in 1996 were small molecule drugs...The drug approvals for 1996 are a reflection of the corporate strategy and the research philosophy embraced by Big Pharma at the time: find drugs that would be utilized by physicians to treat millions of patients suffering from common ailments...The “blockbuster” business model back then focused on having moderately priced drugs broadly prescribed...Companies have not totally abandoned this approach. Last year saw the approval of drugs expected to be billion dollar blockbusters by virtue of treating big populations of patients...What is stunning, however, is to see the number of drugs approved for small or “niche” populations, where high revenues are expected to be generated not by patient numbers but by price. Nowhere is this more evident than in the 14 new cancer drugs...I suspect that, for those who suffer from rare diseases or from certain forms of cancer, this shift in biopharma’s R&D priorities has been welcomed. As shown by the 2015 drug approvals, the promise of favorable pricing did stimulate innovation and improved the health of many. It will be interesting to see if political pressures, particularly in an election year in the U.S., impact this going forward.
- Coverage for Medical-Benefit Drugs a Source of Consumer Confusion (realclearhealth.com)
Patients getting chemotherapy or other complex medications may have a sudden panic when shopping for health insurance: Their drugs often don’t appear to be covered...Despite advice to shop around before selecting a plan, consumers may find that getting answers about drug coverage can be an exercise in frustration, despite a federal health law requirement that insurers provide lists of the prescription medications included in their plans...That’s because many treatments — particularly intravenous treatments like those used in cancer, hemophilia or multiple sclerosis — are covered under a separate part of an insurance plan, not the pharmacy benefit. And details of that medical-benefit drug coverage can be hard or impossible to find online. But the information is important to know because the drugs tend to be costly, so if they’re not covered, patients might have to pay out of pocket, switch to different treatments or appeal to the plan...
- Why FDA Should Oversee Laboratory Developed Tests (blogs.fda.gov)The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies (fda.gov)Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) DRAFT GUIDANCE (fda.gov)Theranos isn’t the only diagnostics company exploiting regulatory loopholes (theverge.com)
Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDT) – tests that are designed, manufactured and used in a single laboratory…But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients...LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results...FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT...the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients…FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.
- 8 Discrepancies in Drug Sales, Prescription Patterns (pharmacytimes.com)
The best-selling brand-name drugs are not necessarily the most-prescribed medications in the United States…IMS Health recently revealed the 50 most-prescribed brand-name drugs and the 50 best-selling brand-name drugs between April 2014 and March 2015…Here are some noteworthy discrepancies between prescription drug sales and prescribing patterns for particular conditions:
- Hepatitis C
- Contraceptives
- Multiple Sclerosis
- Hypertension
- HIV
- Arthritis
- Chronic Obstructive Pulmonary Disease
- Cancer
- Drug approvals at 19-year high belie industry challenges (reuters.com)
2015 was a good year for innovation in medicine with the Food and Drug Administration approving 45 novel drugs, four more than in 2014 and the most since the all-time record of 53 set in 1996...the European Medicines Agency recommended 93 new products, including generics, up from 82 in 2014...the prospect for further progress in 2016, the pharmaceuticals industry faces challenges, with increased political focus on drug pricing having punctured both biotech and specialty pharma valuations in recent months...The rapid pace of new approvals reflects accelerated review times by regulators, who want to get life-saving treatments to patients, especially in cancer, as well as an improved scientific understanding of diseases...Full drug pipelines at many companies suggest the strong rate of new drug launches is likely to continue for a while yet, with IMS Health forecasting a total of 225 new drug approvals between 2016 and 2020.
- How marijuana promoters bypass the law — and the public good (drugtopics.modernmedicine.com)
In California…the “Compassionate Use Act,” too many of us remained quiet about the claims being made by people attempting to promote marijuana for their own agendas…The public approved the use of marijuana for seriously ill Californians to obtain and use marijuana for medical purposes, when recommended by a physician who has determined that the person’s health would benefit from the use of marijuana…There was no need for any placebo-controlled, randomized, FDA–approved study to be conducted — just the physician’s recommendation…The public has been duped by individuals whose main goal is to promote the legalization of marijuana… Keith Stoup, legal counsel for the National Organization for the Reform of Marijuana Laws, was quoted as saying, “We will use [medical marijuana] as a red herring, to give marijuana a good name.”…“in California, marijuana has been de facto legalized under the guise of medical marijuana.”…more than 23 states has approved marijuana for “medical” purposes, and four states and Washington, D.C., have allowed its recreational use, with taxation. To date, this social experiment has met with devastating consequences…Depending on when you graduated from pharmacy school, you pledged an oath. Whether you will abide by that oath to stay educated about pharmaceuticals and be a voice for appropriate drug use is up to you, but the public is relying on you to hold up your end of your oath.
- Global drug spending to hit $1.4 trillion in 2020: IMS (reuters.com)
Global spending on medicines will reach $1.4 trillion in 2020, driven by increased healthcare access in emerging markets and high-priced new drugs for cancer and other diseases…That is up from about $1.07 trillion this year, representing a compound annual growth rate of 4 to 7 percent over the next five years…Some 225 new drugs will come to market over the next five years, about a third aimed at cancer, as well as medicines for rare diseases, which can carry ultra-high price tags, and treatments for autoimmune diseases and heart disease…cost will be partially offset by patent expirations expected to reduce spending on branded medicines by $178 billion, including $41 billion from biologic drugs as cheaper biosimilars become more widely adopted…Developed markets will still account for the lion's share of global spending, about 63 percent, due to higher prices and access to the newest, most expensive treatments.
- Banner Churchill to offer 3D mammography (bannerhealth.com)
Banner Churchill Community Hospital is expanding the imaging capabilities available within the community with the installation of a Hologic 3D Mammography Unit and Dexascan this month. These units will improve patient care and increase efficiency, while offering the convenience of having the scans done close to home...The nonprofit hospital has also upgraded its fluoroscopy machine, bringing state-of-the-art imaging technology for gastrointestinal, cancer and reproductive screenings...“We are pleased to be able to offer the latest technology here at Banner Churchill so patients in our community and the surrounding areas can access the best care without leaving home,” said Dee Towne, senior manager of Medical Imaging.
- Bumper haul of expensive new drugs heads to U.S. and Europe (reuters.com)
Food and Drug Administration has so far approved 37 novel drugs in 2015, more than the 34 that had been cleared by this stage a year ago and just short of 2014's final total of 41…European Medicines Agency is also waving through more products, recommending a total of 84 new medicines so far, up from 75 in the first 11 months of 2014…The brisk pace of new arrivals over the past two years reflects improved productivity in drug research labs and a change of pace by regulators, who have committed to speed up the process of getting life-saving treatments to patients, especially in cancer…The science has got better and we seem to be finding more molecules that are showing material improvements…the rapid pace of new drug launches is forecast to continue, with 225 new drugs expected to be approved between 2016 and 2020…Drug companies argue they need to make decent profits to pay for the billions of dollars needed for drug research. Many companies also have extensive low-cost or even free access schemes for patients who cannot afford their medicines… For healthcare systems in the developed world, paying for such pricey medicines is a challenge - but for many patients in poor countries they will remain out of reach, reflecting the economic realities of drug development.
- Germany, U.S. in hot pursuit of ‘messenger’ drug molecules (newsdaily.com)
A molecule that carries the recipe for making drugs inside body cells is exciting scientists and investors alike, attracting hundreds of millions of dollars in a scramble for the next promising area of biotechnology… synthetic messenger RNA, or mRNA technology, a new approach to tackling a range of hard-to-treat diseases... In theory, the promise of mRNA is enormous, ranging from cancer to infectious diseases to heart and kidney disorders, since it could be used to tackle the 80 percent of proteins that are difficult to affect with existing medicines…In effect, mRNA serves as software that can be injected into the body to instruct ribosomes, the “3D-printers” found inside cells, to churn out desired proteins…This is a radically different approach from conventional approaches, where therapeutic proteins are produced outside the human body and…then be inserted back into the human body at great complexity and cost…“The field is moving very rapidly,”...“I predict it will have a significant impact.”...