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    Featured Health Business Daily Story, Sept. 15, 2011

    New Hepatitis C Drugs Offer Much-Needed Options but With Added Complications

    Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers contain costs and improve outcomes related to high-cost specialty products.

    By Angela Maas
    Managing EditorSeptember 2011
    Volume 8 Issue 9

    Although patient compliance with treatment regimens is important for most therapies, it is particularly crucial for patients with hepatitis C

    This year, May brought the FDA approval of two new therapies for chronic hepatitis C genotype 1 infection. Not only are Merck & Co., Inc.’s Victrelis (boceprevir) and Vertex Pharmaceuticals Inc.’s Incivek (telaprevir) the first oral hepatitis C therapies and the first protease inhibitors approved for the condition, but they also show much more promise than the existing regimen did of actually clearing the virus. Still, the new drugs have their challenges: They have high price tags, and they complicate the standard regimen of pegylated interferon and ribavirin, with which they are used (see story, p. 5). So when the drugs became available in June, specialty pharmacies were quick to incorporate management of the new triple therapies into their existing hepatitis C programs.

    In Express Scripts, Inc.’s Drug Trend Report released in April, the PBM notes that FDA approvals of the two drugs “will increase treatment efficacy and may shorten therapy treatment course as well but will also increase side effects such as anemia. Specialty pharmacy patient management programs are critical to achieve the desired outcomes.”
    Recognizing that, companies already grappling with hepatitis C patient compliance had long been preparing for the therapies.

    Steven Burman, CEO of Burman’s Specialty Pharmacy, explains that before the new drugs were available, his company used a patient-centric strategy and two-prong management approach that involved providing clinical pharmacy management and “alleviat[ing] the administrative burden on physician offices,” tactics that “have served us well over the years. But we knew with the approval of the DAAs [i.e., direct-acting antiviral agents] and response-guided therapy, the clinical management and administrative work to properly manage patients with HCV [i.e., hepatitis C virus] was going to get considerably more challenging.”

    To prepare, he tells SPN, the company spent the previous 18 months developing software that would bring the two prongs “to one central platform,” known as HealthTrac. The “Web-based software system [is] specifically designed to help navigate the complexities of HCV therapy. Using HealthTrac means pharmacists, physicians and other health care professionals can more effectively manage lab work and insurance requirements, supervise patient compliance and communicate regarding patient care.”

    In addition, he says, the software allows the company “to analyze trends across patient groups and evaluate possible treatment options.…Pharmacists, physicians and nurses are all connected through a seamless Web-based system to improve the treatment efficiencies in an effort to improve outcomes.”

    Although patient compliance with treatment regimens is important for most therapies, it is particularly crucial for patients with hepatitis C. According to Richard Faris, vice president and national practice leader for Medco Health Solutions, Inc.’s Rare and Specialty Therapeutics Resource Center, people with less than 85% adherence are “less likely to achieve a sustained virologic response and will not be able to clear the virus.”

    “Hepatitis C patients who have poor adherence or are nonadherent run the risk of developing resistant mutations,” Julie Kulawiec, senior director of specialty disease and market development for Express Scripts, Inc., explains. “Once a patient develops mutations, they are no longer a candidate for successful therapy. Many patients with resistant mutations also can develop cirrhosis or liver cancer. Hepatitis C is the most common condition leading to liver transplants.”
    The new drugs make adherence that much more critical, Faris says, because if people are nonadherent, they can potentially become resistant to protease inhibitor therapy. “There are other drugs with different mechanisms of action in the pipeline,” he says. But according to a July 14 AIS webinar on the specialty drug pipeline, two protease inhibitors are the frontrunners in the hepatitis C pipeline — and those aren’t expected until 2013.

    Recognizing the importance of adherence to treatment regimens, most companies already had management programs dedicated to hepatitis C. For example, CuraScript, Inc., an Express Scripts, Inc. company, has its HepLogic clinical management program, and Axium Healthcare Pharmacy, Inc. has HepVisions. Accredo Health Group Inc., the specialty pharmacy for Medco, has had a hepatitis C therapeutic resource center for five years. All of the companies that spoke with SPN say there is no additional charge for the management services.

    Adherence Is Now Even More Challenging
    But patient compliance with the standard pegylated interferon and ribavirin regimen was already difficult before the addition of the protease inhibitors. Those older drugs have notorious side effects, including flu-like symptoms and depression, that make compliance a real challenge, and the new therapies will only make those effects worse, as well as possibly cause other problems.

    Making sure that patients “are aware of the numerous potential side effects of the medication so that adherence is not compromised” is particularly critical, says Kulawiec. While the manufacturers have educational material, most PBMs and specialty pharmacies also will develop their own packets to give people. Burman even says that his company has developed a “rash kit” for patients prescribed Incivek.

    “The key with all our education is we need to help patients manage themselves in the home environment,” says Faris. Maribel Areopagita, clinical programs manager at Axium Healthcare Pharmacy, Inc., agrees: “Patient education is the cornerstone of effective treatment.”
    Patient compliance is also an issue because of the sheer volume of medication that people have to take. Two to three capsules, and sometimes more, of ribavirin are taken twice a day, and the pegylated interferon is injected subcutaneously once a week, explains Faris. In addition, people on Victrelis will take four capsules three times per day, and Incivek dosing is two tablets taken three times per day.

    “This is a very heavy pill burden for the patient to take,” contends Faris. “It gets to be tough for them to do.”

    In addition, he says, “one of the orals has to be refrigerated, so that makes it more challenging” for compliance. And each of the protease inhibitors has a specific regimen. People taking Incivek stop that treatment after the initial 12 weeks and continue the regimen only with pegylated interferon and ribavirin. And people on Victrelis do not take it for the initial four weeks of treatment.

    Moreover, while both new drugs should be taken with food, Incivek has more stringent dietary requirements, notes Areopagita. Victrelis can be taken before, during or after a meal, which can be either low-fat or high-fat. However, 30 minutes before taking Incivek, people need to eat a meal or snack that has about 20 grams of fat, so Axium provides people with a list of the different kinds of foods that could help them meet this requirement, she says.
    In addition to initial patient education before treatment begins, these specialty pharmacies and PBMs offer ongoing education and assessment during treatment. For example, “Patients receive phone-based clinical assessment and education sessions with CuraScript clinicians on an ongoing basis during their treatment,” explains Kulawiec. “Assessments are scheduled to coincide with periods of potential lapses in therapy to maximize patient care.” The specialty pharmacy, she says, “works with patients to determine whether they are more likely to forget to take their medication during specific periods of the day or on certain days of the week and sets up tools customized for each patient to serve as an extra reminder.”

    Websites with educational material, 24-hour-nurse/pharmacist hotlines and refill reminders are fairly standard as well. For instance, Accredo has a mobile phone application reminder that people can download. Axium, however, tested patient reminders for individual dosages and found that this approach was “too much for patients” who receive “lots of text messages,” says Norbert Cointepoix, director of information technology.
    With the addition of the two new therapies, the already-costly category now has a price tag that has more than doubled. This makes it even more critical to manage members undergoing treatment to make sure they’re taking it correctly and monitoring their response so potential waste is minimized.

    Merck set Victrelis’ weekly price at $1,100, or $26,400 to $48,400 for a course of treatment. Vertex gave Incivek a price tag of $49,200 for a 12-week regimen.
    Depending on patient response, the treatment regimen for Victrelis will be either 28 or 48 weeks; for Incivek, treatment could last for either 24 or 48 weeks. Each drug has specific points in its regimen when lab tests must be done to determine whether patients are responding and, if so, what that response rate is.

    Burman points to a study that shows each patient in which an early viral response (EVR) is identified “can save the health system a minimum of $16,200 via shortened duration of treatment. With approximately 400,000 naive/relapsed patients in the U.S., that represents the potential of reducing the cost burden to the health system by over $4 billion. Additional saving opportunities exist when you consider identifying those less-fortunate patients by applying the FDA futility rules” when patients are not responding, and the FDA recommends halting the therapy.

    “As payers begin to review the DAAs, we believe some will develop medical policies where labs must be captured and reported to the health plan in order for the drugs to be covered,” he adds.
    Kulawiec tells SPN that “as part of CuraScript’s clinical assessment, we obtain and record a patient’s lab results. CuraScript verifies all lab tests done before beginning therapy, four, 12 and 24 weeks post-treatment. CuraScript also verifies the type of hepatitis C that the patient has and that the treatment they are receiving is appropriate. Our clinical assessment schedule follows the recommended lab schedule outlined for hepatitis treatment protocols.”
    Axium has “developed a laboratory algorithm for each patient based upon genotype and therapy. We make scheduled compliance calls to patients and physicians to collect the laboratory information,” Areopagita says.

    And at Walgreen Co., “Our clinicians provide one-on-one side effect counseling and promote cost avoidance based on response guided therapy (higher response rates with the new protease inhibitors and potentially shorter length of therapy) to reflect that we are making recommendations to follow or to stop therapy based on response rates and RGT,” explains Barbara S. Putignano, senior director of specialty pharmacy services. “We request viral load data, and if no or low response to therapy is demonstrated, we contact the doctor with a recommendation,” including potentially discontinuing therapy if there isn’t a response.
    In addition, she says, Walgreens gives payers tools to make sure they understand the RGT protocols with the new drugs. “Walgreens also provides detailed patient-level reporting that can alert payers to patients who may be at risk for nonadherence or off-label use.”
    hepatitiscnewdrugs.blogspot.com


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    if nothing lasts forever then why is love the exception.outkast What do you think about this “review” of my book by someone on Amazon? An informative book if the reader is trying to decide between radiation or surgery only. But if you want to explore other avenues like Hormone Therapy as well as Traditional Chinese Medicine and other alternative modalities, there is no info at all. This is strictly a prostate cancer surgeon talking about which one of these treatment options he eventually chose. The reviewer is right in some respects…my book is limited primarily to the two most common modalities of treating prostate cancer in the USA. This was the intent…take a very complicated decision and go about showing ways to arrive a decision that would be best for the individual taking into consideration the risks of each modality and the specifics of the prostate cancer. It was not meant to be an “end all do all” but “an arrow in one’s quiver” and that is stated in the book. Another thing it does is focus on the abnormal urinary symptoms inherent to each of the treatments and why that is important to consider in any prostate cancer treatment decision. Well he gave me 3 stars and now I am below 5 stars…boo hoo hoo! Can someone throw me a bone and if you found my book helpful write a review for amazon…but not for who you’d think?  The reviews I feel really do help the newly diagnosed prostate cancer in their journey to the decision that best suits them. Reviews tell the reader  a bit about the reviewer (this reviewer is an alternative medicine type) but issues that were important to him and this in turn clues the newly diagnosed patient into issues that may be relevant to them. Finally, hormones are used not for cure and hence don’t have a role in the person making “the decision.” They are used occasionally by the radiation therapist as an adjunct but not as primary treatment option unless the disease is metastatic or the patient’s underlying health dictates its use. Don’t know much about Chinese remedies for prostate cancer.theprostatedecision.wordpress.com


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    HIFU FDA Approval The process for HIFU FDA approval is still ongoing as of today, but clinical trials are already being approved and currently taking place in some of the states in the US. Clinical trials for HIFU began in 2008 wherein the Sonablate®500 is used to trial test those prostate cancer patients who didn’t succeed the treatment using the external beam radiation therapy. The NYU School of Medicine Urology department chairperson Dr.Herbert Lepor said, “It is my pleasure to serve as the medical monitor for the prostate cancer clinical trial program evaluating the safety and effectiveness of the Sonablate(R) 500 HIFU device.” As he said, Dr. Lepor is also in charge for the medical monitoring of the said HIFU treatment and will further study if the HIFU FDA approval could be officially possible. Moreover, he said that “I have personally reviewed the preliminary data and observed the Sonablate(R) 500 in action and I am impressed with this advanced technology for ablating the prostate. These rigorous clinical trials will help define the appropriate role of the Sonablate(R) 500 device in the treatment of prostate cancer.” Initially, there are 10 clinical centers in the US that are conducting the trial. It is not sure for how long the HIFU clinical trial would take place since the aim of the process is to further know how safe and effective HIFU is to prostate cancer patients not just for its short term effect but as well as to look forward on its long term effectiveness and to meet the standards set by the FDA for further marketing approval. As of the moment there are over 100 centers all over the world where HIFU is being used including Asian countries, Europe, Canada, Mexico, North America, and others. In few years time HIFU FDA approval could be achieved since the outcome of the trial testing is showing remarkable performance on prostate cancer patients.hifuprostatecancertreatment.com


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    Hifu Side Effects   Like any other forms of treatment for cancer, HIFU also has numerous risk factors and HIFU side effects. If you are undergoing HIFU treatment, the most common side effects that you will experience are the following: Pain in the areas where treatment is being done such as the scrotum and rectal area Difficulty in urinating Production of protein in the urine or also known as Proteinuria UTI or Urinary tract infection Urine that contains blood or Hematuria Prostate infection or Prostatitis Reversing of semen during ejaculation where it goes back to the bladder rather than coming out from the penis, this is also called Retrograde Ejaculation Painful and swollen scrotum or epididymitis Hematospermia or blood in the fluid produced during ejaculation, semen. Urine leak or urinary incontinence There are also other HIFU side effects that some may experience such as: Contracture on the bladder neck or urethral stricture Rectal fistula or fissures on the walls of the rectum Stool leakage or rectal incontinence Possibility of acquiring the cancer even after treatment Aside from these HIFU side effects, there are also other side effects that could be experienced which are brought by other factors involving the HIFU treatment such as: Chronic pains, head ache, stomach ache, sore throat, and other side effects from the anesthesia as part of the HIFU treatment process Discomfort when applying catheter which may also damage the inside of the bladder Infection and bruising caused by drawing of blood to use in laboratory testing Fatigue, the feeling of being weak after the HIFU treatment procedure Some of the HIFU side effects that are mentioned above could also be a case to case basis and will depend on how the patient’s physical and emotional capability will respond during and after the treatment.hifuprostatecancertreatment.com


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