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Pharmaceutical Manufacturing and Packing Sourcer
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After a massive investment in the NHS in recent years, which has
arguably resulted in little extra productivity, the impetus is now on
value for money or delivering more ‘bang for the buck’. On the whole,
it will be the consumers and healthcare funders who decide where
healthcare resources are allocated in their given geographical areas,
although legal and political factors may continue to affect the
decisions made by the National Institute for Health and Clinical
Excellence (NICE) as to the costeffectiveness of individual treatments
and drugs. Some healthcare funders have chosen not to sponsor certain
drugs or elective operations in their regions, and this is reflected by
the persistence of a ‘postcode lottery’ in the UK regarding other
aspects of healthcare provision.
Changes in Healthcare Delivery
The current economic climate, as well as the change of government, is
producing drastic changes in the way that healthcare must be delivered.
As the primary care physicians take hold of budgets once again, more
local decision-makers will effectively decide which treatments are
available. In addition, there is likely to be far more scrutiny of
outcome measures and cost-effectiveness. From April 2011, hospitals in
the UK will have to show their patient reported outcome measures
(PROMs) – outcome scores that confirm efficacy of treatments and allow
calculations of hospital performance. This added responsibility for GPs
may well bring an increased awareness of value for money than perhaps
was achieved by the past macroeconomic management structures in the
NHS. Arguably, GPs are on the ‘shopfloor’ of healthcare and perhaps in
a better place to evaluate the overall value for money received by the
end-users with an interest beyond the cost of a drug given to a
patient, including the costs of clinics, transport, clinicians and
primary care.
Total Healthcare Cost
Total healthcare cost is the new buzzword for the fund-holders, who
more than ever before must grasp the total overall healthcare costs for
treating a patient. In other words, even if a drug is costly, if its
prescription results in the patient no longer needing significant
primary healthcare support, then overall total healthcare costs may
well be lower. For injectable medicines this raises a simple question –
will GP fund-holders bear the additional costs for simple injections if
patients can self-medicate, and will they tolerate the use of
injections that don’t comply with needle-safe statutes?
A district nurse visit costs approximately £80 to £100, while private
deliveries of home injections cost up to £1,000 a visit; therefore, the
potential healthcare savings produced by technologies that allow
patients to self-medicate are substantial. A staggering 85 per cent
reduction in healthcare costs (allied to enhanced patient compliance)
has been demonstrated for the injectable biological drugs,
self-injected at home as opposed to in healthcare settings. Five per
cent of the western population have an autoimmune disease, which is
likely to be the biggest sector – along with oncology – requiring new
injectable biologic medications to come to market.
Patient Factors
Patient education has advanced rapidly in the last few years and the
doctor-patient relationship has evolved dramatically. Patients are
happier to take responsibility for their own healthcare and now
question time-honoured practices. Patients are no longer prepared, nor
can they afford to spend time in clinics awaiting simple treatments
they know they could easily do themselves and, provided they are
offered safe alternatives, are only too happy to self-medicate. For
patients, their employers and social security funders, the financial
implications of this release from a healthcare-centric existence to
normality are self-evident. Pre-filled syringes and auto-injectors are
at the forefront of this revolution. From the viewpoint of injectable
drugs, two points are very clear:
- Significant direct cost savings are achieved if patients can self-treat at home with their medications
- Needle-safe devices are effectively now a statutory requirement
to diminish the one million healthcare needle-stick injuries per year
in the EU
The Move towards Self-Administration by Auto-Injectors
Considering the NHS requirement for reduced total healthcare costs, in
the context of the injectable market, the imperative is on
pharmaceuticals that can be self-medicated using suitable auto-injector
devices via the subcutaneous, intradermal or intramuscular routes.
Studies have shown that auto-injectors provide an 85 to 95 per cent
reduction in injectable drug costs compared to the administration of
injections by healthcare staff or clinicians based in a primary
healthcare setting. Patients, employers and healthcare providers are
realising the importance of selftreatment both in reducing primary
healthcare costs and improving a patient’s wellbeing – not least
because patients no longer have to visit a hospital to receive their
medication. Auto-injectors also optimise compliance as they reduce
administration errors, thus lowering the risk of disease complications.
A comment by a patient sums up the advantages of this method: “Not only
did the auto-injector probably cost less than the car parking to attend
hospital, but I no longer have to take half a day off work once a
fortnight”.
Growth in the Use of Pre-Filled Syringes
The past five years have witnessed major growth in the pre-filled
syringe (PFS) market as the importance of safety, security, accurate
dosage, anti-tampering and counterfeit protection provided by such
devices has been realised by patients, physicians, regulators,
healthcare funders and pharmaceutical companies. Clinical research
papers provide evidence to support this common-sense view and show that
drug administration errors are greatly reduced via the use of PFS. For
example, in one study that relied on manual syringe filling rather than
pre-filled syringes, it was shown that many incorrect doses of
magnesium were given in a one-week period in an intensive care unit
(ICU) treating cardiac events, with large dosage errors being
observed.The message is that injectable products ideally need to be
provided in clearly labelled pre-filled syringes that minimise
administration error, and ideally in combination with needle safe
devices.
The Need for Auto-Injectors that Incorporate Pre-Filled Syringes
The key point about the design of autoinjectors for pre-filled syringes
is that the regulatory route to market is fast and cost-effective. If
the primary drug pack, which includes the needle, syringe and stopper,
remains unchanged then there is no need to perform further
timeconsuming and expensive drug trials.The regulatory environment,
cost and time factors are ensuring that PFS remains the format of
choice and that auto-injectors are being developed to accept this
format without changing the primary pack in any way. In fact,we believe
that the use of auto-injectors will become mandatory as the regulatory
environment demands injectors that prevent needlestick
injury.Healthcare providers are also demanding devices that reduce
primary healthcare costs by allowing patients to self-medicate.
Requirement for Needle-Safe Devices
Major international imperatives are underway to further regulate
healthcare environments in an attempt to reduce the incidence of
needle-stick injuries. In the US, 500,000 sharps injuries are reported
each year (with up to another 50 per cent going unreported), with
similar numbers in Europe. In general, healthcare workers report 0.5 to
3.4 sharps injuries per year. Similarly, patients who self-medicate
have voiced concerns over the safety of family members in a home
environment where there are unprotected needles.
The NHS and private healthcare suppliers in the UK are waking up to the
financial implications of needle-stick injuries. Recent payouts to
individuals as a consequence of receiving a needlestick injury have
been in excess of £1 million when healthcare providers have been found
to be at fault.The authority responsible for liability within the NHS
has made it clear that defending such incidents would be impossible
unless the healthcare providers had taken all steps reasonably possible
within their financial constraints to ensure adequate needle safety.
Although individual hospitals trusts have Crown indemnity, insurance
premiums reflect local trust risk management practices – so every
needle-stick injury directly affects the resources remaining for
healthcare provision.
It is clear that the days of non needlesafe vials and ‘naked’ needles
are over. Auto-injectors require needle safety with features that
prevent accidental needle-stick injury and pharmaceutical companies are
rushing to upgrade first generation auto-injectors with inadequate
needle safety.
Major Market Growth in Biologics Developed in Pre-filled Syringes
The global pharmaceutical market is now worth approximately $600
billion and most analysts are predicting that 15 to 40 per cent of
pharmaceutical revenues will be from biologics by 2015. While some
companies such as Roche spotted the upcoming growth in the biologics
market as early as 1990 by merging with Genentech and are currently
market leaders in the biotechnology industry with revenues from
biologics at $36 billion in 2009 (followed by Amgen with revenues of
$14.7 billion), some of the other large pharmaceutical companies have
not yet followed this pathway.
A number of other major pharma companies were forecast in 2010 to
generate no sales from biologics, instead relying on revenues from
traditional small molecule product sales.However, even companies such
as AstraZeneca and Merck & Co have recently made bids to acquire
biological drug development and some are even considering the
previously unthinkable option of competing with their own generic
versions. Pfizer said it would follow Merck and other companies into
the area of biosimilars and biologics with a further three follow-on
products for rheumatoid arthritis in Phase III development.Merck also
said it expects to seek regulatory approval of five new drugs with 45
per cent of its clinical pipeline coming from its takeover of
Schering-Plough. Even Novartis, which was forecast to record the second
strongest growth rate in big Pharma in 2010, has decided to enter the
generics market as well as positioned itself strongly to enter the
emerging biosimilars market.Whichever pathway the large pharmaceutical
companies have chosen, it is clear that biologics will become a major
part of the pharmaceutical revenue of the biggest companies and that
this will be reflected by the increased development and use of
pre-filled syringes.
New Injectables and Pre-Filled Syringes
There are currently around 550 biological therapeutics (antibody-based
drugs) in late stage development and about two thirds of the
injectables are in PFS format. There are 30 branded antibodies
currently available on the European market with worldwide sales of $129
billion. Five products dominate the biologics market – with Avastin,
Remicade, Rituxan and Humira accounting for 75 per cent of sales – and
many of the current drugs are administered using auto-injectors. The
patents of many of the currently available biological drugs have
already expired or will expire in the next few years, and although
there are no generic monoclonal antibodies approved in the US or
Europe, they are predicted to reach the market between 2014 and 2016.
New entries to this market will have to compete not only in terms of
cost and bioequivalence, but also in terms of the ease and cost of
administration.
The message is clear: if you have an injectable, it has to be cheaper,
as effective as the previous product and it must have a PFS, ideally
with an autoinjector for self-administration, as well as meeting all
needle-safety regulations. If you do not have an auto-injector, you
should be aware that all of your competitors will.
Growth in High Viscosity Injectables – Protein, Sustained Release and Depot Formulations
The new antibody-based biological therapies often have high viscosity
as they must be delivered at high concentration in small volumes. In
addition, the market need for reduced dosage frequency is being met by
PEGylation and related technologies, sustained release and depot
formulations, which also tend to have very high viscosities.
Patients cannot self-administer high viscosity formulations as they are
challenging to inject even for healthcare professionals – very high
forces are required to inject viscous fluids through fine gauge
needles. Fine gauge needles are required to minimise patient pain but
the use of conventional syringes is currently a commercial requirement
as it greatly reduces the regulatory challenges and the cost and speed
to market.This means that there is a growing market need for medical
auto-injectors that can deliver high viscosity drugs using conventional
needles and syringes.Given the regulator’s preference for zero per cent
failure rate, first generation devices cannot currently meet this
challenge and even low viscosity formulations often require a
significant force that can result in a high percentage of glassware
failures.
Manufacturers have developed specialised syringes to cope with the
forces required for viscous drugs and have worked to improve the
manufacturing tolerances that affect auto-injector performance.
Recently we have seen the emergence of plastic syringes, such as CZ
materials, which claim to offer enhanced protection, although they may
have different compatibilities with biological medicines compared to
glass.
Perhaps the key requirement is that new auto-injectors for delivery of
high viscosity biologics must be able to use the existing packaging
formats. Autoinjectors for viscous drugs must be easy to use, leave the
primary pack unchanged and meet emerging global needle-stick
regulations.
Lyophilised Drugs
Exponential growth is also expected in the lyophilised drug
sector.There are few, if any, devices available to deliver these
products in an acceptable manner. Such drugs require a multi-chamber,
multistep process to reconstitute the drug and then deliver it. New
auto-injectors for lyophilised drugs are also emerging but they face
the same challenges of ease of use, patient conformity and safety.
Conclusion
The major market for injectables is moving towards the development of
biologic and sustained-release medicines in pre-filled syringes
combined with auto-injectors, or towards lyophilised
presentations.Newer products need new devices, as most existing devices
fail to deliver drugs of any significant viscosity and only a few meet
emerging needlestick regulations.New syringe and cartridge designs are
similarly required, and devices are needed to deliver the exponential
growth expected with lyophilised presentations.The major driver with
the new biologic and sustained release drugs is a reduction in overall
healthcare costs. Selfmedication reduces primary healthcare costs by as
much as 85 per cent and providing needle-safe devices significantly
reduces the incidence and cost to the healthcare providers of third
party needle-stick injury.
In addition, PFS and auto-injectors have been shown to markedly
increase compliance even with well-established medicines, again
contributing to improved healthcare outcomes and a reduced overall cost
of treatment.The regulators are demanding needle-safe devices and the
healthcare providers and patients are demanding autoinjector solutions
for the cost and lifestyle benefits that they produce.The major
emerging challenge is to develop auto-injectors that can use the
existing delicate glass PFS, thereby avoiding expensive re-regulation,
to deliver the many emerging viscous medications. They must achieve
this without breaking the syringes and with zero failure rates. While
only a limited number of devices are out there, there are hundreds of
new drugs coming to market, some of which have very specific physical
requirements demanding newer auto-injector capabilities, and with many
disease areas fully and exclusively licensed. Eventually, there will be
a shortage of auto-injector intellectual property to meet demand, and
late-comers to the market may find themselves unable to deliver their
product.
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