Ahead of his presentation at Connect to Frankfurt (opening September 28^th) – a new digital platform to begin your journey to CPHI Frankfurt – David Young from Chemicals Knowledge Hub spoke exclusively with Aaron Wright, Analyst EMEA Thought Leadership at IQVIA. He looks ahead at the lasting implications of the pandemic and the new era of providing medicines outside of hospital settings. Wright suggests that we are at pivotal moment and pharma companies have a unique opportunity to seize on this momentum by engaging with policymakers to diversify the locations a patient can receive care. This will allow flexibility within the healthcare system and give patients the best experience possible.

Connect to Frankfurt is specifically designed for CPHI attendees to get the most out of their CPHI Frankfurt experience – even before they attend – it presents more than 30 on-demand webinars, and offers a head start on networking, meetings, and understanding the very latest in pharma industry developments.

The online platform is accessible to anyone registered for CPHI Frankfurt (November 1-3, 2022) – the world largest pharma event – and will remain open post event until 18^th November.

Chemicals Knowledge Hub: Why the trend towards near home care?

Wright: “The trend towards “near-to-home” care is part of a broader movement within the healthcare and pharmaceutical industries that has been occurring over the last twenty years. From the advent of biologic products in the early 2000’s through to the emergence of indication-agnostic therapies such as checkpoint inhibitors, and advanced therapies such as cell and gene therapies, medicines have become more personalised. New techniques have also contributed to the growth of personalised medicine, with genotyping and biomarkers playing an important role, especially for indication-agnostic therapies.

Alongside personalised medicine, patient-centric approaches to care are becoming more prominent. These range from increased information availability through ePortals to a greater usage of Electronic Health Records (EHRs). Patient centricity has also been a point of focus in clinical development. The inclusion of Patient Advocacy Groups (PAGs) in clinical trials is becoming more common, and decentralised clinical trials (DCTs) have been able to eliminate much of the burden associated with trial participation for patients[i].”

Chemicals Knowledge Hub: Why is now the right time for this shift?

Wright: “The need, and the benefits, of moving care out of the hospital and nearer to the patient has been illuminated by the COVID-19 pandemic, as healthcare systems resorted to abnormal operating procedures to reduce the burden of dealing with a large influx of patients. Funding constraints have become an even greater issue, with COVID-19 vaccines alone forecast to cost a total $251bn globally by 2026[ii]. Wait times have also been impacted. At the same time, the pandemic has negatively impacted healthcare professionals (HCPs), with one in three clinicians considering leaving their job by 2024[iii].

Despite these herculean challenges, the pandemic has also provided opportunities. As a result of attempts to limit in-person interaction, telehealth services increased exponentially[iv]. For example, Germany implemented several changes including reimbursement for postal dispatch of prescriptions and special regulations for prescribing home nursing, and NHS England issued interim guidance to reduce the frequency of in-person interactions in order to free up capacity[v]^,[vi].”

Chemicals Knowledge Hub: what is near-to-home care?

Wright: “There is no one-size-fits-all approach to a system of near-to-home care, but where and when care itself is administered is the primary definition. Some examples are:

Outpatient clinics, which can provide complex treatment but may require patients to travel some distance (although still shorter than traveling to a relatively fewer number of hospitals).

Mobile clinics, which can travel to more remote/rural patients and still provide complex treatments like an outpatient centre, but at a smaller throughput due to their smaller physical size.

Local pharmacies, which are more numerous and more local than outpatient clinics, but still require patients to travel and are unlikely to be able to administer treatments more complex than IV formulations.

At-home treatment, with or without an assisting HCP. At-home treatment is the most convenient option for patients but requires significant investment in logistics and personnel.”

Chemicals Knowledge Hub: are any indications more suited to near home?

Wright: “Near-to-home care is suitable for both primary and secondary care and across high-value therapy areas. The top 3 therapy areas by value in 2021 in Europe (oncology, immunology and antithrombotics) were all compatible with a near-to-home care system. So too are orphan medicines for rare diseases: Onpattro, a medication for hATTR amyloidosis, is available for home administration in Italy through Alnylam Italia’s AMYCARE programme[vii].”

Chemicals Knowledge Hub: How do formulations and devices fit into this picture?

Wright: “Globally between 2016 and 2021, Humira saw sales of autoinjector formulations grow by 14% CAGR whereas sales of subcutaneous vials shrank by -33 CAGR. In the same period, European autoinjector sales grew at 19% CAGR[viii]. Manufacturers are racing to develop more patient-friendly formulations, such as in the checkpoint inhibitor market where companies are looking to develop subcutaneous formulations to differentiate their brands in a highly competitive market[ix]. Phesgo is another example; combining two pre-existing IV treatments (pertuzumab and trastuzumab) into one subcutaneous product has reduced administration time from 2.5 hours to 5 minutes[x]. Shifting drug formulations to simpler formulations including subcutaneous and oral formulations can allow for a greater number of products to be administered either by patients themselves, or in basic facilities by nurses.

Changes in the drug delivery device (DDD) market are also occurring in line with changes to product formulations. In the major seven developed pharmaceutical markets (US, Japan, EU4 & UK) between 2016-2021 and looking at a subset of high-value therapy areas (immunology, oncology, respiratory, diabetes, human growth factor), the number of autoinjectors sold has grown at 36% CAGR, compared to pre-filled pens at only 2% CAGR. In total, parenterals with a hidden needle nearly quadrupled their market share from 5% to 19% in the same period[xi].”

Chemicals Knowledge Hub: What are the main hurdles to overcome in Europe?

Wright: “Regulatory: For example, in Spain, the home sale of prescription medicines is outlawed at the national level, severely handicapping the delivery of at-home care[xii]. France allows for home delivery of hospital medications, but it is heavily restricted, again impeding one major aspect of near-to-home care. Regulatory vagueness also plays a role and can create uncertainty for care providers and pharma companies. Italy currently has no legal framework for the home delivery of drugs. Despite this, some schemes have been implemented by pharma companies, although these schemes have raised concerns surrounding fair access to medicines.

Financial: Sufficient financial frameworks and incentives will need to be in place to ensure near-to-home care can reach its full potential. Neither Italy nor Spain has the national-level frameworks available to support home care, though individual regions may choose to implement their own due to the highly regionalised nature of these countries healthcare systems.

Financial incentives to encourage healthcare systems to switch to a new modality, and pharma and wholesalers to develop solutions for the new landscape, are currently lacking. Developing new reimbursement pathways for the administration of hospital medicines in community pharmacies would entice pharmacists to provide new services as one example.

Behavioural: Healthcare systems are large, complex organisms, and as a result large-scale organisational changes face significant institutional momentum. This behavioural hesitancy differs from country to country; in the UK, recommendations to make greater use of homecare providers to dispense hospital medicines have been around since 2016[xiii]. Comparatively in Germany, the prevalence of ASV centres may make implementation of additional near-to-home care solutions more difficult.

Behavioural challenges also occur at the individual level. Despite the increased usage of telehealth systems by HCPs, there are varying levels of confidence in how effective and easy to use they are for diagnosis, treatment and monitoring[xiv]. This is also true of patients; whilst many may prefer the increased convenience of telehealth solutions, others may prefer to see a doctor face-to-face, or may not be technologically literate enough to use the solutions themselves.

Logistical: A shift to near-to-home care brings with it substantially more endpoints involved in the care delivery process and will require reconfiguring storage and transport logistics. Effective storage of medications must be considered, especially for high-value immunology or oncology products. Specialty medications, particularly those that require extra-cold storage present challenges as well, as many homes or pharmacies may not have compliant facilities to store them. So too must the deliveries be protected to ensure they arrive securely. Technological solutions such as ePrescriptions and tracked deliveries may be the answer here.

Ensuring adequate personnel are available is also important. An expansion of near-to-home care would require many more HCPs, in particular nurses, to deal with the many more care endpoints.”

Chemicals Knowledge Hub: What the positive implications for the pharma industry?

Wright: “Rather than being seen as a threat, there are a number of new opportunities presented by this potential shift for those who are willing to commit to the changing healthcare landscape:

Healthcare systems: Near-to-home care offers a new model of health system, one focused on individual patients rather than a traditional, hospital-first approach. This format will reduce the number of patients requiring admission by moving as much care as possible out of the hospital, reducing the burden on strained HCPs and reducing costs to healthcare systems.

To achieve these benefits, policy makers must work to actively promote near-to-home care elements. This will involve addressing issues surrounding limiting or unclear regulations, implementing financial frameworks, and working to shift institutional and individual behaviours. Policy makers should work with the pharmaceutical industry to encourage the development of formulations that can be self-administered or administered outside the hospital by HCPs, as well as technological and logistical systems to support near-to-home care.

Pharma companies: Drug manufacturers will be able to gain access to a greater patient population in the near-to-home care market, potentially increasing sales revenues and helping fulfil any Environmental, Social or Governance (ESG) commitments made surrounding increasing access to medicine. By developing more-easily administrable formulations and more convenient DDDs, pharma companies can mitigate competition from competitors, especially as patients will have more choice over their treatments than ever before.

Pharma should prioritise engaging with policy makers to ensure regulations promote near-to-home care products and systems and the implementation of clear financial frameworks and incentives. Reaching out to HCPs will also be required, to explain the benefits of telehealth systems and alleviate any concerns they may have surrounding the technologies.

Wholesalers: As near-to-home healthcare systems can use community pharmacies for distribution of hospital drugs instead of hospital ones, wholesalers can take advantage of this new financial disbursement channel. Furthermore, if health systems choose to use pharmacies as an administration point for medicines, wholesalers can look to be reimbursed for these appointments, adding an element of service provision to their business model.

Separately, the distribution of medicines to patient’s homes will require gathering large amounts of patient-related health data. This type of data will prove highly lucrative as pharma companies and healthcare regulators are increasingly looking to use real-world evidence in their decision making.

Wholesalers should focus on working with policy makers to ensure there are no legal hindrances to the delivery of hospital medicines to patient residences, or for service provision within pharmacies. Due to the increased logistical requirements of near-to-home care, wholesalers should also seek to invest in the greater logistical and human resources that will be required, such as methods of cold chain delivery and last-mile delivery solutions.

A detailed analysis on this topic will also be presented in the CPHI Annual Report 2022 – released during CPHI Frankfurt – with implications for the 2023 and beyond.

[i] 71% of investigators agree that DCTs reduce the burden on participants – IQVIA Decentralised Trials Fact Sheet, 06/01/2022. Available at: https://www.iqvia.com/library/fact-sheets/iqvia-virtual-trials

[ii] The Impact of COVID-19 Pandemic on the Healthcare Industry: Oncologists’ and Surgeons’ views, SONY and Censuswide. Available at: https://assets.pro.sony.eu/Web/healthcare/smart-imaging-platform/EN-covid-impact-whitepaper.pdf

[iii] Elsevier Health: Clinical of the Future, March 2022. Available at: https://www.elsevier.com/__data/assets/pdf_file/0004/1242490/Clinician-of-the-future-report-online.pdf

[iv] COVID Future perspective in terms of patient management and care – EU4, UK & US, IQVIA

[v] SARS-CoV-2-Arzneimittelversorgungsverordnung, Federal Ministry of Health. Available at: https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/guv-19-lp/sars-cov-2-arzneimittelversorgungs-vo.html

[vi] Visiting healthcare inpatient settings during the COVID-19 pandemic, NHS England, Originally published 16/03/2020, updated 07/06/2022. Available at: https://www.england.nhs.uk/coronavirus/publication/visitor-guidance/

[vii] Amyloidosis and COVID-19, Alnylam launches the “AMYCARE” program, Osservatorio Malattie Rare, 28/05/2020. Available at: https://www.osservatoriomalattierare.it/malattie-rare/amiloidosi/16111-amiloidosi-e-covid-19-alnylam-lancia-il-programma-amycare

[viii] IQVIA MIDAS Quarterly MAT Q4 2016 – 2021

[ix] https://pharmaphorum.com/news/roche-scores-phase-3-win-for-subcutaneous-tecentriq-eyes-filings/

[x]  https://www.bbc.co.uk/news/uk-england-merseyside-56648455

[xi] IQVIA MIDAS Quarterly MAT Q4 2016 – 2021.

[xii] Royal Legislative Decree 1/2015, of July 24, approving the consolidated text of the Law on guarantees and rational use of medicines and medical devices, Ministry of Health, Social Services and Equality, 25/07/2015. Available at: https://www.boe.es/buscar/doc.php?id=BOE-A-2015-8343

[xiii] Operational productivity and performance in English NHS acute hospitals: Unwarranted variations, Lord Carter of Coles, February 2016. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/499229/Operational_productivity_A.pdf

[xiv] COVID Future perspective in terms of patient management and care – EU4, UK & US, IQVIA