- FDA approves a Gilead pill that is first to treat all forms of hepatitis C (statnews.com)
Gilead Sciences won regulatory approval...to sell a new hepatitis C combination drug, which can combat all six strains of the disease, and priced it below its older treatments...Epclusa, combines the older Sovaldi (sofosbuvir)medication with the newer velpatasvir, and costs $74,760 for a 12-week course of treatment, although that’s before any rebates are offered to payers. This is less than the list prices for both Sovaldi and Harvoni, another Gilead hepatitis C treatment...Gilead has argued its treatments are more affordable than paying for liver transplants, cancer, and hospitalizations. To what extent the newest drug will cause payers concern is unclear. Epclusa will cost roughly half of the most commonly used treatment regimen for patients with Genotype 3 of the disease...(which)...is...the most difficult to treat and one of the reasons Epclusa was granted priority review by the FDA...One consumer advocate charged the pricing for the new drug was out of line...Gilead still doesn’t get it — their pricing is outrageous. Once again, Gilead has shown that it is more concerned with protecting its profits rather than making its drugs available to all Americans...
- Panel Would Make Insurers Help Contain Rising Drug CostsPanel Would Make Insurers Help Contain Rising Drug Costs (nytimes.com)
An influential federal advisory panel is calling for Congress to force private insurers to rein in rapid increases in prescription drug costs — by cutting some Medicare payments to insurance companies while shielding older Americans from higher out-of-pocket expenses...The recommendations by the nonpartisan Medicare Payment Advisory Commission would squeeze private insurers and drug makers alike, creating strong new incentives for insurance companies to manage the use of prescription medicines by beneficiaries and negotiate larger price discounts with pharmaceutical manufacturers...The recommendations will be included in a June report to Congress, which often heeds the panel’s advice...More than 40 million of the 56 million Medicare beneficiaries have drug coverage through Part D, and national surveys indicate that most are satisfied with the coverage. But out-of-pocket costs for some beneficiaries have increased in recent years as insurers require them to pay 25 percent or more of the cost for expensive specialty drugs to treat chronic or complex illnesses, including cancer, rheumatoid arthritis, multiple sclerosis and hepatitis C...Pharmaceutical companies and advocates for beneficiaries said some of the panel’s recommendations could harm patients’ access to certain medicines and raise costs for some low-income people...
- Drug spending increase slowed to 5.2 percent last year, Express Scripts says (statnews.com)
Despite rising prices for prescription medicines, Express Scripts released data today showing spending for its health plans rose 5.2 percent in 2015, roughly half of what was seen the year before...the average price of brand-name drugs rose 16.2 percent in 2015...Most of the increased spending was for specialty medications — such as those for hepatitis C, cancer, and other hard-to-treat diseases. Spending for these drugs rose nearly 18 percent, compared with a 0.1 percent drop for traditional drugs for chronic conditions...usage rose nearly 7 percent for specialty medicines, compared with 2 percent for other drugs...Express Scripts boasted that it has successfully used various techniques to manage drug costs. These include formularies with various so-called tiers, which are lists of preferred drugs that require consumers to pay varying amounts. Another tactic is prior authorization, which involves requiring consumers to try different treatments before a more expensive medicine...Another move...was...to curtail coverage of many compounded medications...Total spending on compounded treatments for pain and skin conditions fell 54 percent as usage dropped 56 percent.
- Nevada’s first outpatient palliative care clinic for children opens (reviewjournal.com)
Local nonprofit Cure 4 the Kids Foundation announced...the creation of the first outpatient palliative care clinic specifically for children in Nevada...The Pediatric Palliative Care Clinic, which is supported by Cure 4 the Kids, debuted last month in Las Vegas at the Children's Specialty Center of Nevada... Having a child with complex medical issues is often overwhelming for parents and these special kids. The palliative program will offer the child and family the support they need...It focuses on providing relief to the symptoms of serious conditions such as cancer and genetic disorders whether or not the affected person is still seeking treatment...The center's services aren't akin to immediate end-of-life care...Instead, children affected by what the center calls "life-limiting" diseases will receive care without having to be admitted to the hospital...Although the cost of care may be covered by a family's major medical benefits, the services will be provided regardless of a family's ability to pay...
- Novartis splits drugs business into two, pharma chief to leave (reuters.com)
Novartis is splitting its pharmaceuticals division into two business units, one focused on cancer and the second on other drugs, while switching out its current pharma head in the second high-profile management reshuffle this year...David Epstein, the American head of Novartis Pharmaceuticals...will leave the company to "explore new challenges from the U.S."...Epstein's re-location to the United States implies he is not in the running to replace Andrew Witty as chief executive of British drugmaker GlaxoSmithKline next year...Novartis' reorganization of its main drugs unit, which accounts for about two-thirds of its $49 billion in annual sales, shows the growing importance of oncology to the company...Cancer drugs tend to enjoy high profit margins and the therapy area is highly valued by investors at present, thanks to recent advances in fighting the disease and the premium prices commanded by cancer treatments...A split makes sense because oncology now has critical mass, following the GSK deal, and oncology is in many ways becoming a differentiated business from the rest of pharmaceuticals...
- Former Shkreli-led drug developer pledges responsible pricing (reuters.com)
A biotechnology company, previously led by controversial former drug executive Martin Shkreli, on Monday vowed not to engage in aggressive pricing and to develop a transparent and 'responsible' pricing model for its products...KaloBios Pharmaceuticals Inc, which fired chief executive Shkreli last December...is developing drugs to treat Chagas disease and cancer, said...that it intended to price its products at overall cost, plus a 'reasonable and transparent' profit margin, if and when they are ready for marketing...There exist no approved drugs for Chagas disease in the United States or Europe. However, benznidazole is cleared for use in Latin America, and is considered the standard-of-care treatment in the region...We are not conducting original research on benznidazole and therefore do not plan to incorporate an 'R&D premium' into the price...
- Engineers 3D Print Tissue That Mimics How The Human Liver Functions (forbes.com)
Engineers at the University of California...say they have successfully 3D printed life-like liver tissue that simulates how the human liver functions and is structured. The researchers say the tissue could be used as a platform for drug screening...In the case of Federal Drug Administration approval for a drug, on average it takes around 11 to 14 years and $2.6 billion to get a drug to market...Around 90% of drugs don’t pass animal tests or human clinical trials. In the case of the new 3D printed tissue, the researchers say pharmaceutical companies could use the tissue as platform in the lab to focus on drugs that appear to be more promising and eliminate drugs that have less efficacy...To create the liver tissue that mimics real human liver tissue, the engineers created a diverse combination of liver cells and supporting cells systematically organized in a hexagonal pattern under a microscope. But to print that complex tissue, they needed a 3D printer that could accommodate the 3D micro-structures found in biological tissue. The team created their own bioprinting tech in the lab capable of reproducing the elements and features of the tissue…I think that this will serve as a great drug screening tool for pharmaceutical companies and that our 3D bioprinting technology opens the door for patient-specific organ printing in the future. The liver tissue constructed by this novel 3D printing technology will also be extremely useful in reproducing in vitro disease models such as hepatitis, cirrhosis and cancer...
- Medical errors are third-leading cause of death in United States: Study (cnbc.com)Medical error—the third leading cause of death in the US (bmj.com)
Go to the doctor or hospital when you're sick in the hopes of getting better, and you might end up dead, instead...A new study estimates that medical errors are actually the third-leading cause of death in the United States, responsible for a whopping 251,454 fatalities in 2013...Only heart disease and cancer, which respectively killed 611,000 people and 585,000 people that year, outpaced medical errors...death from medical error has been understated, in large part, because such error by health providers is not included on death certificates...There is no official disease code for medical error, and death certificates rely on such codes...As a result, causes of death not associated with an ICD code, such as human and system factors, are not captured..."human error is inevitable" and "we cannot eliminate human error, we can better measure the problem to design safer systems mitigating its frequency, visibility and consequences."
- Drug dosing goes digital with software to personalize medication (statnews.com)Individualizing liver transplant immunosuppression using a phenotypic personalized medicine platform (stm.sciencemag.org)
A new algorithm may take the guesswork out of medicating patients with cancer, bacterial infections, organ transplants, and other conditions that require very precise drug dosing...Individual differences can alter patient response to medications...Metabolism, body type, ethnicity, other illnesses, and genetics can play a role in how patients respond to drug treatment...The researchers call their method parabolic personalized dosing, or PPD. They gave patients medication and then observed the dosages which brought positive responses...the dosage could be reduced or increased based on how much medication was in the patient’s blood, with the successful doses added to the parabola. The researchers called the parabola "a robust map that identifies drug doses (inputs) that ensure that a patient will stay in a target range."...Establishing a patient’s parabola still requires administering drugs and then observing the response, something doctors already do. "This allows us to make a better guess,"...In the age of big data, algorithms could play a helpful role in integrating a lot of patient information to make dosing decisions.
- India’s Pharmaceutical Market to Skyrocket from $20B to $55B by 2020 (dddmag.com)
The pharmaceuticals market in India, valued at $20 billion in 2015, is set to soar to $55 billion by 2020, representing an impressive Compound Annual Growth Rate of 22.4 percent...India’s rapidly growing generics market is the primary driver of the nation’s pharmaceutical sector, with sales expected to soar by nearly 84percent to $26.1 billion in 2016. Generic drugs, with their low costs and easy accessibility, now dominate India’s pharmaceutical space, accounting for around 70 percent of the market...India supplies 20 percent of global generic medicines in terms of export volume, making the country the largest provider of generic medicines globally...Another driver of India’s pharmaceutical sector is the potentially lucrative biosimilars market, which is expected to increase to $40 billion globally by 2020, as biologic treatments are introduced for diseases such as diabetes, cancer, multiple sclerosis, and rheumatoid arthritis...