Alignment across countries and among regulators, health technology assessment bodies and payers would help manufacturers define research policies that can drive innovation, but may be challenging, as judgements about what aspects of innovation should be rewarded vary among stakeholders, and depend on political and societal factors.
Background: For many chronic immune system disorders, the available treatments provide several options for route of administration. The objective of this systematic literature review is to inform discussions about therapy choices for individual patients by summarizing the available evidence regarding the preferences of patients with chronic immune system disorders for intravenous (IV) or subcutaneous (SC) administration. Methods: Searches of the MEDLINE, Embase and Cochrane Library databases were conducted using terms designed to capture studies reporting patient preferences between IV and SC therapy published in English. Relevant studies were limited to those in which mode of administration, including treatment frequency and setting, was the main difference between comparators. Results: In total, 49 studies were included in the review. Among 18 studies that compared IV and SC immunoglobulin therapy, 16 found patients to prefer the SC administration route. The results of the 31 studies comparing IV infusion and SC injection of non-immunoglobulin therapies were mixed, with patients favoring SC administration in 20, IV infusion in seven, and having no overall preference in four. Patient experience had a strong effect on preferences, with treatment-experienced patients preferring their current administration route in most studies. Patients preferring SC administration tended also to prefer treatment at home, mainly due to the convenience and comfort of home treatment and the avoidance of having to attend hospital. By contrast, patients preferring IV infusion tended to cite the lower treatment frequency and a dislike of self-injecting, and preferred hospital treatment, mainly due to the presence of healthcare professionals and resulting feelings of safety. Conclusion:In general patients with chronic immune system disorders tend to be more likely to choose SC administration than IV infusion, but preferences may vary according among individuals. These findings may assist discussions around appropriate treatment choices for each patient.
Clinical studies have demonstrated the benefits of abiraterone acetate + prednisone (AAP) and enzalutamide (ENZ) in significantly improving survival among metastatic castration‐resistant prostate cancer (mCRPC) patients. However, evidence regarding patient's real‐world experience, particularly with respect to fatigue, treatment satisfaction and health‐related quality of life (HRQoL) is limited. Interviews were initially conducted with patients (n = 38) and carers (n = 12) to elicit qualitative data regarding their experiences. Findings informed the design of a quantitative, multinational online survey of mCRPC patients (n = 152) receiving AAP or ENZ. Participants completed validated questionnaires assessing fatigue (Brief Fatigue Inventory), treatment satisfaction (Cancer Therapy Satisfaction Questionnaire) and HRQoL (EuroQol‐5‐Dimensions). Results indicated that patients were generally satisfied with these therapies, more specifically with reductions in prostate‐specific antigen levels and extended survival. Fatigue was commonly linked to poor HRQoL and responses indicated that significantly fewer patients in the AAP group reported feeling usually tired or fatigued in the last week compared to the ENZ group (33% vs. 55%, p = 0.006 respectively). Findings highlight the benefit of AAP and ENZ in promoting the “quality” of extended survival. That fatigue was lower among patients receiving AAP may be important for informing treatment decisions. Further research is needed to gain deeper insights.
With finite resources, healthcare payers must make difficult choices regarding spending and the ethical distribution of funds. Here, we describe some of the ethical issues surrounding inequity in healthcare in nine major European countries, using cancer care as an example. To identify relevant studies, we conducted a systematic literature search. The results of the literature review suggest that although prevention, access to early diagnosis, and radiotherapy are key factors associated with good outcomes in oncology, public and political attention often focusses on the availability of pharmacological treatments. In some countries this focus may divert funding towards cancer drugs, for example through specific cancer drugs funds, leading to reduced expenditure on other areas of cancer care, including prevention, and potentially on other diseases. In addition, as highly effective, expensive agents are developed, the use of value-based approaches may lead to unacceptable impacts on health budgets, leading to a potential need to re-evaluate current cost-effectiveness thresholds. We anticipate that the question of how to fund new therapies equitably will become even more challenging in the future, with the advent of expensive, innovative, breakthrough treatments in other therapeutic areas.Electronic supplementary materialThe online version of this article (doi:10.1007/s40258-016-0288-4) contains supplementary material, which is available to authorized users.
Current methods of assessing affordability in healthcare may be limited by their focus on budget impact. A more effective approach may involve a broader perspective than is currently described in the literature, to consider the long-term benefits of a therapy and cost savings elsewhere in the healthcare system, as well as cooperation between healthcare payers and the pharmaceutical industry to develop financing models that support sustainability as well as innovation.
Objectives: Abiraterone acetate and enzalutamide, novel anti-androgen therapies with distinct modes of action for the treatment of metastatic castration-resistant prostate cancer (mCRPC), are approved in both the pre-chemotherapy and postchemotherapy settings. These anti-androgen therapies have significantly improved outcomes among mCRPC patients. However, to date there is little published evidence regarding patients' real-world experience of these therapies in both the pre-chemotherapy or post-chemotherapy settings, particularly in terms of health-related quality of life (HRQoL) and treatment satisfaction. MethOds: Qualitative face-toface interviews were conducted with mCRPC patients (n= 38) and carers (n= 12) to obtain in-depth data concerning the patient experience with novel anti-androgen therapy. This included patients with experience of abiraterone acetate or enzalutamide in either the pre-chemotherapy or post-chemotherapy setting in France, Germany and the UK. Findings from this study have been used to inform the design of a larger quantitative, multinational online survey to further explore and quantify HRQoL and treatment satisfaction among mCRPC patients receiving anti-androgen therapy. Results: Patients generally had high expectations at initiation of therapy with a primary emphasis on reduction in prostate-specific antigen levels and improvements in HRQoL. Patients and carers reported that experiences on treatment had met or exceeded expectations. Administration procedures appeared to be of limited concern for patients and only mentioned by patients when prompted by directive questions. In particular, the need to take abiraterone acetate on an empty stomach was not deemed problematic. Some differences in the patient experience (e.g. side effects) and HRQoL of patients receiving abiraterone acetate and enzalutamide were noted and warrant further exploration. cOnclusiOns: Patients and carers reported largely positive experiences with novel anti-androgen therapies for the treatment of mCRPC. Potential differences between regimens in terms of treatment satisfaction and HRQoL are currently being explored in a larger quantitative online study.
A435 1.352) and 0.385(0.248; 0.596) respectively for OS and PFS. Survival extrapolation provided estimates of 8 month of additional OS gain for Lenvatinib vs. sorafenib, with MAIC extrapolation showing largest gain and a good model fit. ConClusions: This analysis demonstrated that in absence of head-to-head trials, MAIC is an important methodology to adjust for population and trial differences, especially in orphan diseases where limited data are available. MAIC can increase reliability of comparativeeffectiveness data and support payers decision making.
Objectives: Abiraterone acetate and enzalutamide, novel anti-androgen therapies with distinct modes of action for the treatment of metastatic castration-resistant prostate cancer (mCRPC), are approved in both the pre-chemotherapy and postchemotherapy settings. These anti-androgen therapies have significantly improved outcomes among mCRPC patients. However, to date there is little published evidence regarding patients' real-world experience of these therapies in both the pre-chemotherapy or post-chemotherapy settings, particularly in terms of health-related quality of life (HRQoL) and treatment satisfaction. MethOds: Qualitative face-toface interviews were conducted with mCRPC patients (n= 38) and carers (n= 12) to obtain in-depth data concerning the patient experience with novel anti-androgen therapy. This included patients with experience of abiraterone acetate or enzalutamide in either the pre-chemotherapy or post-chemotherapy setting in France, Germany and the UK. Findings from this study have been used to inform the design of a larger quantitative, multinational online survey to further explore and quantify HRQoL and treatment satisfaction among mCRPC patients receiving anti-androgen therapy. Results: Patients generally had high expectations at initiation of therapy with a primary emphasis on reduction in prostate-specific antigen levels and improvements in HRQoL. Patients and carers reported that experiences on treatment had met or exceeded expectations. Administration procedures appeared to be of limited concern for patients and only mentioned by patients when prompted by directive questions. In particular, the need to take abiraterone acetate on an empty stomach was not deemed problematic. Some differences in the patient experience (e.g. side effects) and HRQoL of patients receiving abiraterone acetate and enzalutamide were noted and warrant further exploration. cOnclusiOns: Patients and carers reported largely positive experiences with novel anti-androgen therapies for the treatment of mCRPC. Potential differences between regimens in terms of treatment satisfaction and HRQoL are currently being explored in a larger quantitative online study.
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