Tag: treatment

12 Jun 2018

Skip the Chemo?

Breast cancer treatments have made impressive strides in terms of increasing survival rates for patients; however, a huge new study reveals that chemotherapy may not be as important of a factor for some women with breast cancer as previously thought. In fact, in some categories of breast cancer, most patients who received chemotherapy may not have actually benefitted from it. In other words, these patients would have survived just as well without the addition of chemotherapy.

This new research, which was discussed at the American Society of Clinical Oncology and published in the New England Journal of Medicine, could lead to an overhaul of the decision making process, as experts rely on better research-based guidelines to decide which patients should (and which shouldn’t) have chemotherapy added to their plan of care.

Chemotherapy generally brings painful side effects for patients, although those can certainly be worth it if life is extended. In a decade-long study of more than 10,000 women with breast cancer, there was no benefit of chemotherapy for patients with the most common type of breast cancer. Specifically, this common type of breast cancer is characterized as hormone-receptor–positive, HER2-negative, axillary node–negative breast cancer with a midrange 21-gene recurrence score. Women with this most common breast cancer did not garner benefits from chemotherapy, as opposed to surgery and hormone therapy. (There were exceptions; however, for some younger women and some women older than age 50.)

What Does This All Really Mean?

Up to 70% of women with the most common type of breast cancer don’t need chemotherapy (which means these women can also skip the nausea, hair loss, and anemia that chemotherapy generally brings with it).

This new study adds to our understanding of breast cancer treatment and continues to create a clearer picture of how to personalize treatment based on each individual’s specific tumor qualities.

The take-away is this: each year in the U.S. there are now 70,000 women with breast cancer who might be able to skip chemotherapy and still have the same chance of beating this disease. Of course, it’s best for patients to discuss with their oncologists about what is the best course of treatment for their specific situation.

Source

Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. New Engl J Med June 3, 2018 DOI: 10.1056/NEJMoa1804710

05 Jun 2018

New Hope in Ulcerative Colitis

Xeljanz (tofacitinib) garnered a lot of interest back in 2012 when it was developed and approved for the treatment of rheumatoid arthritis. Then, in 2017, studies found that this oral medication also treated psoriatic arthritis and FDA approval was added for that indication.

Last week, yet another FDA approval for Xeljanz came: this medication now has an expanded FDA approval for adults with moderately to severely active ulcerative colitis. This makes Xeljanz the first oral prescription option for ulcerative colitis. In other words, this is big news and a potential game changer for the nearly one million Americans with this form of inflammatory bowel disease. All of the other FDA-approved treatments for chronic ulcerative colitis involve either intravenous infusion or subcutaneous injection. So, clearly, an oral alternative is welcome news to many patients.

This latest FDA approval was spurred after results from three clinical trials in patients with ulcerative colitis showed remission for patients on Xeljanz in up to 47% of patients taking the medication long term. Safety data was collected, with the more common adverse effects being diarrhea, elevated cholesterol levels, and headache. Although there are some less common adverse effects that led to Xeljanz coming with a box warning for serious infections and malignancy. Xeljanz cannot be used at the same time as biological therapies or with potent immunosuppressants (e.g., azathioprine and cyclosporine).

Inflammatory bowel diseases, which include both ulcerative colitis and Crohn’s disease, are chronic inflammatory diseases of the bowel. They can develop as a result of genetic or environmental factors (e.g., smoking, diet, or any alteration of the normal human gut flora) that trigger an immune response, which in turn creates mucosal damage to the GI tract.

Symptoms of inflammatory bowel disease range from diarrhea, abdominal pain, and perianal fistulas to fatigue, weight loss, and/or bowel obstruction. While ulcerative colitis is more closely associated with changes to the inner lining of the colon, Crohn’s disease can affect any segment of the gastrointestinal tract: all the way from mouth to anus.

The BioPlus Specialty Pharmacy team is ready to help patients and their health care providers access Xeljanz for ulcerative colitis.

Source

Press release. FDA approves new treatment for moderately to severely active ulcerative colitis. FDA May 30, 2018.

08 May 2018

Patient Access = Patient Treatment

When medications exceed the financial resources of a patient, it can create a seemingly insurmountable barrier to accessing important treatment. It’s pretty hard to get better if you can’t fill (or refill) your prescribed medications. Here at BioPlus we spend a lot of time thinking about patient access to treatment, which is why we’ve long had a patient financial assistance program to help patients overcome financial roadblocks to their treatment.

Did you know that someone with cancer is 2.5 times more likely than another person from the general population to file for bankruptcy? This is how serious the financial challenges of a health crisis can be. It gets worse, though. When severe financial distress results in bankruptcy, that itself becomes a risk factor for worsened survival times. Although there is variation, based on the type of cancer a person has, about 3% of cancer patients end up bankrupt. These patients, in turn, are nearly 80% more likely to die than non-bankrupt cancer patients.

By now you’re probably getting the idea that research clearly connects the dots between the patient portion of the cost of medication and whether or not patients can start or refill their prescriptions. Furthermore, the connection between adherence and patient outcome is clearly known: non-adherent patients face worse health outcomes and greater disease complications. And, as you also probably know, we’re in the business of helping patients get better.

Our financial assistance department is a key part of our overall service of RxExpress – which makes BioPlus faster than most other specialty pharmacies for taking a prescription from hot-off-the-prescriber’s-pad to a patient’s hands. It all starts with our 2-Hour Patient Acceptance Guarantee that streamlines the first step of the specialty pharmacy process. Our 2-Day Ready 2 Ship program follows close behind, which gets prescriptions ready to ship in just two days. The financial assistance for our patients is an integral part of this entire process.

The financial assistance department at BioPlus assists and supports patients with ways to connect with financial resources, helping patients access foundation grants and co-pay assistance programs. Looking over the past year, for example, our financial assistance team connected patients with $35 million of financial assistance, which allowed many patients with financial barriers to be able to start and continue their important treatment. We’re aiming even higher this year.

Sources

Sharp L, O’Leary E, O’Ceilleachair A, Skally M, Hanly P. Financial impact of colorectal cancer and its consequences: associations between cancer-related financial stress and strain and health-related quality of life. Dis Colon Rectum 2018;61:27-35.

Ramsey SD, Bansal A, Fedorenko CR, et al. Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol 2016;34(9):980-6.

Lathan CS, Cronin A, Tucker-Seeley R, et al. Association of financial strain with symptom burden and quality of life for patients with lung or colorectal cancer. J Clin Oncol 2016 JCO632232. [Epub ahead of print]

17 Apr 2018

Introducing New Prostate Cancer Treatment, Available from BioPlus

A new medication has joined the ranks of potential treatment for prostate cancer. The FDA recently approved Janssen’s Erleada™ (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but continues to grow despite treatment with hormone therapy (castration-resistant). BioPlus Specialty Pharmacy can help patients get started with Erleada and support them during the treatment process.

Erleada is only available through a limited distribution network of specialty pharmacies, which now includes BioPlus. This oral medication earned FDA approval months ahead of the scheduled decision date and is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. The FDA’s fast approval turnaround of Erleada was based on clinical trials of this medication showing a 72% reduction in risk of metastasis or death. There are currently 2.9 million American men who were previously diagnosed with prostate cancer who are still alive. This medication will only be increasing this impressive number.

For men, prostate cancer remains the second most common type of cancer. Only skin cancer is more prevalent. Over the course of his lifetime, one in every seven men will develop prostate cancer and one in 39 men will die of prostate cancer. The difference in those numbers means that lots of men are surviving this disease and with Erleada now available those survival numbers should continue to go up.

Source

Press release. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. U.S. Food and Drug Administration February 14, 2018.

06 Mar 2018

Personalizing Crohn’s Disease Treatment

Guest blog by: Marianne Shenouda, Pharm.D., Clinical Pharmacy Specialist, BioPlus Specialty Pharmacy

Inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis, are chronic inflammatory diseases of the bowel. These diseases can develop as a result of genetic or environmental factors, such as smoking, diet, or any alteration of the normal human gut flora. These factors spur a progressive immune response, which in turn creates mucosal damage to the GI tract.

Symptoms of inflammatory bowel disease run the gamut from diarrhea, abdominal pain, and perianal fistulas to fatigue, weight loss, and/or bowel obstruction. While ulcerative colitis is more closely associated with changes to the inner lining of the colon, Crohn’s disease can affect any segment of the gastrointestinal tract: all the way from mouth to anus.

Treatment for Crohn’s disease focuses on two main types of medications: anti-inflammatory agents and biological treatments. The biological treatments include many medication options: Humira, Remicade, Cimzia, Stelara, Entyvio, and Tysabri. These medications work to alter the immune response of the immune system, by targeting specific proteins that cause inflammation. Humira, for example, targets a protein called TNF-alpha.

Crohn’s disease biological medications can bring great benefits to patients; but unfortunately it is not uncommon for a particular medication to become less effective over time. However, monitoring certain elements of the immune system can guide future treatment. Specifically, monitoring levels of adalimumab antibodies (ATAs) can allow determination if a patient needs a dose increase or if it is appropriate for the patient to switch to another medication within the same drug class. It appears that low trough concentrations may be reflective of a loss of response to Humira (trough levels less than or equal to 5 mcg/ml). In this case, testing for antibodies is suggested. For trough concentrations above 5 mcg/ml, the presence of antibodies are not likely, so the patient may benefit from an increased dose. It was also suggested that adalimumab concentration results above 35 mcg/mL should be drawn at a different time-point other than trough.

Overall ATA testing could lead to a more appropriate and cost-effective management strategy for patients with Crohn’s disease, which is part of an overall move to more personalized treatment of disease.

Sources:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991576/

https://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/64863

30 Jan 2018

Breast Cancer Treatment Options Expanding

Targeted cancer therapies aim to best match the treatment to specific characteristics of cancer cells. Increasingly, breast cancer treatment is based on targeted therapy medications. With targeted therapy, the harm to healthy cells can be lessened and thus side effects can be less severe than from traditional chemotherapy.

Earlier this month, the FDA approved a new targeted therapy for BRCA-positive, HER2-negative metastatic breast cancer: Lynparza (olaparib). Previously, Lynparza was approved for treating some types of ovarian cancer. Lynparza is a PARP inhibitor. The PARP enzyme’s role is to fix DNA damage, but it does this fixing to both healthy and cancerous cells. By blocking this enzyme, Lynparza helps keep breast cancer cells from growing.

Just about a quarter of patients with hereditary breast cancers and up to one in every ten patients with any type of breast cancer have a BRCA mutation. Women with breast cancer can take a genetic blood test, called the BRACAnalysis CDx, which indicates whether Lynparza would be appropriate targeted cancer therapy for their breast cancer. The results with Lynparza are promising, with a reduction in disease progression or death by 42%, when compared to traditional chemotherapy.

This was not the only good news about breast cancer this month. Kisqali (ribociclib) from Novartis received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer. Kisqali is a cyclin-dependent kinase 4/6 inhibitor (like the medication Ibrance), which means it works by blocking a certain protein needed in cell division.

The pipeline of new targeted therapies for breast cancer is important news, especially in light of the fact that premenopausal breast cancer remains the leading cause of cancer death in women 20-59 years old.

By The Numbers

12.4%  Women in the U.S. who will be diagnosed with breast cancer at some point in life

266,120  Number of new breast cancer patients estimated in 2018

3.1 million  U.S. women with a history of breast cancer

85%  Women who develop breast cancer despite no family history

Sources

FDA approves first treatment for breast cancer with a certain inherited genetic mutation. FDA News Release January 12, 2018.

Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer. Press release January 3, 2018.

16 Jan 2018

Cost Concerns

The financial hardships of a serious illness can be daunting. Even for those with health insurance, the medical bills and pharmacy costs can accumulate, along with a potential loss of income while treating and recovering from a disease.

In a recent survey of nearly 500 people after successful colorectal cancer treatment, financial challenges were reported by four in 10 patients. This same proportion of people similarly noted that their concerns about home finances created stress, which of course piled on to the stress of facing cancer. These financial stressors correlated with a decrease in quality of life for patients.

Study after study shows that the financial burdens of treating serious health problems does in fact impact quality of life and even health outcomes. This financial burden – which is often referred to as financial toxicity – is a growing concern for patients and their families. In fact, patients may even delay treatment due to cost concerns. In one survey of 609 individuals with chronic hepatitis C, fully one-third were not currently being treated specifically due to cost concerns. This is unacceptable.

Overcoming financial challenges is one of the ways BioPlus Specialty Pharmacy supports our patients during the treatment process. Our patient financial assistance department works to ensure that financial barriers are overcome so patient treatment can both start and continue. In just three quarters of 2017 we connected oncology patients with $30 million in patient assistance, in the form of grants, co-pay assistance, and donations. We take our responsibility seriously in assisting and supporting patients with ways to connect with financial resources. In short, we aim to resolve financial toxicity issues while treating a patient’s disease.

Sources

Sharp L, O’Leary E, O’Ceilleachair A, Skally M, Hanly P. Financial impact of colorectal cancer and its consequences: associations between cancer-related financial stress and strain and health-related quality of life. Dis Colon Rectum 2018;61:27-35.

Survey: Hepatitis C patients delay treatment due to cost concerns. Health UnionOctober 4, 2017.